FDA UDI
In Commercial Distribution
🇺🇸 United States
Cartilage Biopsy Transport Medium
DI: 00850037506187
·
Model: 21263
·
VERICEL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Cartilage Biopsy Transport Medium
- Primary DI
- 00850037506187
- Version / Model
- 21263
- Company Name
- VERICEL CORPORATION
- Labeler DUNS
- 079745570
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-13
- Public Version
- 1
- Public Version Date
- 2022-12-21
- Public Version Status
- New
- Public Device Record Key
- 38494075-f633-4729-b149-5cd89b9989c9
Device Description
DMEM with HEPES, Gentamicin, and Glutamax
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KIT | Media And Components, Synthetic Cell And Tissue Culture | Hematology | 864.2220 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58567 | Cell culture medium IVD | A liquid based tissue culture medium containing essential nutrients, sugars, amino acids and growth factors, intended to be used for the in-vitro maintenance, sustenance, and cultivation of human cells from a clinical specimen for diagnostic purposes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850037506187 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Refrigerate Cartilage Biopsy Transport Medium at +2°C to +8°C (36°F to 46°F)
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do no expose Cartilage Biopsy Transport Medium to direct sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not freeze Cartilage Biopsy Transport Medium
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius