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Nalgene™ Cryogenic Tube, 2 mL externally-threaded

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref 5000-0020

by Nalge Nunc International Corporation

Identity

Trade Name
Nalgene™ Cryogenic Tube 2 mL externally-threaded EUDAMED
Nalgene™ Cryogenic Tube, 2 mL externally-threaded FDA UDI
Generic Name
General specimen container IVD, no additive/medium FDA UDI
Device Name
Cryogenic Tubes EUDAMED
CRYOGENIC VIAL 2.0ML, PPCO FDA UDI
Model / Reference
5000-0020 EUDAMEDFDA UDI
Description
CRYOGENIC VIAL 2.0ML, PPCO FDA UDI

Identifiers

Primary DI / UDI-DI
10850016058598 EUDAMEDFDA UDI
Basic UDI-DI
0850016058477758Z EUDAMED
Unit of Use DI
80850016058597 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 EUDAMED
Class I FDA UDI
Regulation Number
864.3250 FDA UDI
Market of Registration
Denmark EUDAMED
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

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
Sterilization Method
Radiation Sterilization FDA UDI

Nalgene™ Cryogenic Tube, 2 mL externally-threaded 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

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Manufacturer

Manufacturer
Nalge Nunc International Corporation

Sources (2)

  • FDA UDI 4e4df098-62f7-4da9-b7c6-a9f549e8847a 34 fields · synced Jul 14, 2026
  • EUDAMED e9b170ae-4dc9-43b8-9af8-6db17fce460f 61 fields · synced Jul 14, 2026