Nalgene™ Specimen Cryogenic Vial, 15 mL externally-threaded
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Nalgene™ Specimen Cryogenic Vial 15 mL externally-threaded EUDAMEDNalgene™ Specimen Cryogenic Vial, 15 mL externally-threaded FDA UDI
- Generic Name
- General specimen container IVD, no additive/medium FDA UDI
- Device Name
- Cryogenic Tubes EUDAMEDCRYOGENIC VIAL SPEC PP; 15ML FDA UDI
- Model / Reference
- 5005-0015 EUDAMEDFDA UDI
- Description
- CRYOGENIC VIAL SPEC PP; 15ML FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10850016058673 EUDAMEDFDA UDI
- Basic UDI-DI
- 0850016058477758Z EUDAMED
- Unit of Use DI
- 80850016058672 EUDAMED
- FDA Product Code
- FMH FDA UDI
- EMDN Code
- W050299 DEVICES FOR SAMPLES TRANSPORT - OTHER EUDAMED
- GMDN Term
- General specimen container IVD, no additive/medium FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3250 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: General specimen container IVD, no additive/medium
Nalgene™ Specimen Cryogenic Vial, 15 mL externally-threaded by Nalge Nunc International Corporation — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
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 b23e2781-2892-4504-a01b-a6f00ba203e9 33 fields · synced Jun 18, 2026
- EUDAMED bd2db10e-5896-4381-bf71-466050cd2cdf 61 fields · synced Jun 18, 2026