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Nalgene™ Cryogenic Tube, 5 mL externally-threaded, Barcoded
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Nalgene™ Cryogenic Tube, 5 mL externally-threaded, Barcoded FDA UDI
- Generic Name
- General specimen container IVD, no additive/medium FDA UDI
- Device Name
- CRYOGENIC VIAL,BAR CODED FDA UDI
- Model / Reference
- 5001-0050 FDA UDI
- Description
- CRYOGENIC VIAL,BAR CODED FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10850016058659 FDA UDI
- FDA Product Code
- FMH FDA UDI
- GMDN Term
- General specimen container IVD, no additive/medium FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3250 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Radiation Sterilization FDA UDI
Nalgene™ Cryogenic Tube, 5 mL externally-threaded, Barcoded by Nalge Nunc International Corporation — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Nalge Nunc International Corporation
Sources (2)
- FDA UDI 268d1e0a-e9ff-4ba0-ae35-a922c2cc36f3 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 18, 2026