Nalgene™ Cryogenic Tube, 5 mL externally-threaded

Basic Information

• Brand Name: Nalgene™ Cryogenic Tube, 5 mL externally-threaded
• Primary DI: 10850016058604
• Version / Model: 5000-0050
• Company Name: Nalge Nunc International Corporation
• Labeler DUNS: 080844844
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2022-07-26
• Public Version: 1
• Public Version Date: 2022-08-03
• Public Version Status: New
• Public Device Record Key: 9c936952-ddde-4f5c-bc9c-95582e3ca59f

Device Description

CRYOGENIC VIAL, PPCO; 5.0ML

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMH	CONTAINER, SPECIMEN, STERILE	Pathology	864.3250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47775	General specimen container IVD, no additive/medium	An empty covered receptacle containing no additives or media intended to be used for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, tissue) derived from different body regions for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30850016058608	GS1	Case	250	In Commercial Distribution
Primary	10850016058604	GS1
Unit of Use	80850016058603	GS1