Label product

On this page, you will find the labels on the packaging of a product. The image shows the GS1 Data Source ID. The table below explains what it means.

 

 

GDSN information on product packaging / label 

GS1 Data Source ID 

BMS ID 

Explanation 

Tip 

Used  Symbol  

Meaning of symbol and (code to be entered) 

1120 

1598 

Manufacturer Declared Reusability Type Code 

 

 

 

 

SINGLE_USE 

1126 

1593 

Initial Manufacturer Sterilisation Code 

 

 

 

ETO_ETHYLENE_OXIDE 

 

 

 

GAMMA_RADIATION 

 

 

 

DRY_HEAT 

 

 

 

 HYDROGEN_OXIDE 

 

 

 

NOT_STERILISED 

1127 

1594 

Initial Sterilisation Prior to Use Code 
Check 1126 for options 

 

 

 

Except for the code Not Sterilised (NOT_STERILISED) 

1119 

1581 

MRI Compatibility Code 

Afbeelding 

 

 

 

 

 

 

 

MRI_SAFE 

 

 

MRI_COMPATIBLE 

 

 

MRI_UNSAFE 

 

 

Choose unspecified (UNSPECIFIED) if nothing is stated on the label 

4723 

6364 

UDI Production Identifier Type Code                                   A batch number is indicated in the label as lot number  

 

 

 Lot or batch number (BATCH_NUMBER) 

 

4723 

6364 

UDI Production Identifier Type Code 

 

 

 

SERIAL_NUMBER 

4723 

6364 

UDI Production Identifier Type Code 

 

 

clessidra 

 

MANUFACTURING_DATE 

 

EXPIRATION_DATE 

2603 

3070 

Regulation Type Code   Indication whether the product has a CE mark 

 

 

CE marking (CE) 

3059 

67 

GTIN (Global Trade Item Number) 
See barcode on the label/packaging  

- 

N/A 

3060 

68 + 69 

Additional Trade Item Identification 

 

 

 

 

Reference number (MANUFACTURER_PART_NUMBER) 
 
Additional trade item identification assigned by the supplier in addition to GTIN and reference number (SUPPLIER_ASSIGNED) 

 

 

3074 

66 

Trade Item Unit Descriptor For example: box of 30 pieces 

- 

N/A 

3098 

93 

Manufacturer name 

 

 

 

Legal Manufacturer 

3122 

161 

Global Product Classification: GPC Brick Indication that the product is a medical device 

 

Afbeelding 

 

Medical Device (10005844) 

3254 

144 

Effective Date Time  Effective Date Time concerns the date on which the specific version of the product information/label/packaging is valid 

- 

N/A 

3318 

3517 

Trade Item Description 

- 

Concerns the product description as it appears in the label of the packaging in the language or languages of the target market and any other languages used on the label. It is recommended to use brand name, function, net content, and, applicable at the box level, quantity of the next lower trade item. 

3336 

3541 

Brand Name 

- 

N.v.t. 

3599 

3820+3821 

Maximum Temperature and measurement unit 

 

 

 

Temperature limitations – maximum temperature in degrees Celsius 

3608 

3826+3827 

Minimum Temperature and measurement unit 

 

 

 

Temperature limitations – maximum temperature in degrees Celsius 

4166 

1583 

UDID Device Count. 

(sometimes indicated with a symbol) 

 

Number of items present in the base unit 

 

Other possible symbols on a packaging/label 

993 

1434 

Does Trade Item Contain Latex 

 

 

 

Is there an indication on the item that the item contains latex (TRUE of FALSE) 

5317+5318 

7237+7233 

Claim Type Code and Element Claim Code 

 

 

 

Contains  Phthalates (PHTHALATE) 

Mention a code from the ‘ClaimTypeCode’ codelist. If the item contains phthalates, select 'CONTAINS' for the 'Code type claim'. If the item does not contain phthalates, select 'FREE_FROM'. In case of doubt, select 'CONTAINS'. 

 

4522 

6089 

Does Trade Item Contain Human Tissue 

 

 

     

 

Contains human blood or plasma Derivates. 

 

Contains biological material of human origin. 

To be indicated with TRUE 

 

 

 

 

 

 

 

 

GS1 Data Source ID 

BMS ID 

Explanation 

Tip 

Used  Symbol  

Meaning of symbol and (code to be entered) 

243 

665 

Certification Agency 

 

- 

Refers to the name of the organisation that issued the certification (notified body) 

246 

685 

Certification Value 

 

- 

Refers to the number of the certificate 

251 

682 

Certification Effective End Date Time 

 

- 

Refers to the date from which the CE certificate will expire 

239 

668 / 669 

Additional Certification Organisation Identifier (- Additional Party Identification Type Code) 

 

- 

The identification number of the certifying organisation/notified body. Use code ‘EU Notified Body Number (EU_NOTIFIED_BODY_NUMBER)’ 

 

3132 / 3131 

173 / 171 

Additional Trade Item Classification Code Value / Additional Trade Item Classification System Code 
 

  

  

  

  

  

  

  

  

  

 

Refers to the risk class of the device 
 
If the product is certified under the MDR or IVDR, use code 76 and one of the following values:  
EU_CLASS_I, EU_CLASS_IIA, EU_CLASS_IIB, EU_CLASS_III, EU_CLASS_A, EU_CLASS_B, EU_CLASS_C, EU_CLASS_D. 

  
If the product is certified under the MDD, rIMDD of IVDD, use code 85 and one of the following values:   

EU_CLASS_I, EU_CLASS_IIA, EU_CLASS_IIB, EU_CLASS_III, IVDD_ANNEX_II_LIST_A, IVDD_ANNEX_II_LIST_B, IVDD_DEVICES_SELF_TESTING, IVDD_GENERAL. 

1118 

1580 

Is Trade Item Implantable 

 

- 

Indication of whether the product is implantable or not (TRUE or FALSE) 

5214 

7110 

Required Education or Training Type Code 

 

- 

Indication of whether training or education by the user is required to use/handle/operate the product: 

Safe use (SAFE_USE) 

Reprocessing product (REPROCESSING_PRODUCT) 
Other (OTHER) 

5216 

7103 

Pre-cleaning Indicator 

 

- 

Indication of whether the product requires additional pre-cleaning (TRUE or FALSE) 

5215 

7106 

Cleaning Disinfection Process Code 

 

- 

Indication of the process type for cleaning or disinfection: 

Automated(AUTOMATED) 

Manual (MANUAL) 

Automated or manual (AUTOMATED_MANUAL) 
To be indicated in combination with ‘Product Cleaning Type Code’ or ‘Product Disinfection Type Code’. 
 

5217 

7104 

Product Cleaning Type Code 

 

- 

Indication of the type of cleaning/detergent for the (pre-)cleaning of the product 
Alkaline detergent (ALKALINE_DETERGENT) 

Brushing (internal) (BRUSHING_INTERNAL) 

Brushing (external) (BRUSHING_EXTERNAL) 

Soaking (SOAKING) 

Mild alkaline detergent (MILD_ALKALINE_DETERGENT) 

PH neutral/enzymatic detergent (PH_NEUTRAL_ENZYMATIC_DETERGENT) 

Flushing (FLUSHING) 

Water rinsing (WATER_RINSING) 

Ultrasonication (ULTRASONICATION) 

5218 

7108 

Product Disinfection Type Code 

 

- 

Indication of the type of disinfection for the disinfection of the product 

Glutaraldehyde (GLUTARALDEHYDE) 

Peracetic acid (PERACETIC_ACID 

Thermal disinfection (THERMAL_DISINFECTION) 

3614 

3820 

Temperature activity code 

 

- 

Indication of the specified temperature for storage or sterilisation. 

During storage or handling (STORAGE_HANDLING) 

Sterilisation (STERILISATION) 

3587 

3399 

Handling Instructions Code Reference 

 

- 

Aanduiding voor de opslaginformatie 

Store at Room Temperature (SRT) 

Store in freezer (FPC) 

Refrigeration Required (11) 

3826 / 3827 

3608 

Minimum Temperature 

 

- 

Indication of the minimum temperature for storage handling in Celsius degrees  
OR 
Indication of the minimum sterilisation temperature in Celsius degrees 

3820 / 3821 

3599 

Maximum Temperature 

 

- 

Indication of the maximum temperature for storage handling in Celsius degrees  
OR 
Indication of the maximum sterilisation temperature in Celsius degrees 

 

8599 

7011 

Minimum Process Temperature Timespan 

  

- 

Indication of the minimum time in which the product can be processed without affecting product safety or quality in relation the the sterilisation temperature 

8602 

7012 

Maximum Process Temperature Timespan 

 

- 

Indication of the maximum time in which the product can be processed without affecting product safety or quality in relation the the sterilisation temperature 

5223 

7112 

Resistance to a Surface Tension Reducing Agent Indicator 

 

- 

Indication whether the product is resistant to a surface tension reducing agent  
(TRUE or FALSE) 

5254 

7176 

Waste Code 

 

- 

Indication of the type of waste that is created from the product: 

Chemical waste (CHEMICAL_WASTE) 

Hazardous medical waste (HAZARDOUS_MEDICAL_WASTE) 

Recyclable waste (RECYCLABLE_WASTE) 

Residual waste (RESIDUAL_WASTE) 

Sharp medical objects (SHARP_MEDICAL_OBJECTS)