FDA UDI
In Commercial Distribution
🇺🇸 United States
Nalgene™ Cryogenic Tube, 1.2 mL externally-threaded, Barcoded
DI: 10850016058635
·
Model: 5001-0012
·
Nalge Nunc International Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
25
Basic Information
- Brand Name
- Nalgene™ Cryogenic Tube, 1.2 mL externally-threaded, Barcoded
- Primary DI
- 10850016058635
- Version / Model
- 5001-0012
- Company Name
- Nalge Nunc International Corporation
- Labeler DUNS
- 080844844
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2022-07-26
- Public Version
- 2
- Public Version Date
- 2024-02-12
- Public Version Status
- Update
- Public Device Record Key
- dc4fe170-882e-4888-b904-bea44223f878
- Distribution End Date
- 2024-07-28
Device Description
CRYOGENIC VIAL,BAR CODED
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 | 30850016058639 | GS1 | Case | 500 | In Commercial Distribution | 2024-07-28 |
| Primary | 10850016058635 | GS1 | ||||
| Unit of Use | 80850016058634 | GS1 |