FDA UDI
In Commercial Distribution
🇺🇸 United States
Skin Biopsy Transport Kit
DI: 00860004093008
·
Model: 0
·
VERICEL CORPORATION
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Skin Biopsy Transport Kit
- Primary DI
- 00860004093008
- Version / Model
- 0
- Company Name
- VERICEL CORPORATION
- Labeler DUNS
- 079745570
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-09-24
- Public Version
- 2
- Public Version Date
- 2023-08-15
- Public Version Status
- Update
- Public Device Record Key
- f042a1e0-3f2b-4213-8248-765bbdb531f7
Device Description
The Skin Biopsy Transport Kit, developed by Vericel Corporation, provides a way for surgeons to preserve a live skin biopsy and return it to the Vericel Cambridge Manufacturing Facility for the production of EPICEL - (Container, specimen mailer and storage, temperature controlled, sterile)
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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KDW | Container, Specimen Mailer And Storage, Temperature Controlled, Sterile | Pathology | 864.3250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15743 | Specimen container mailer, insulated | A non-sterile tube, box, or envelope designed to transport a specimen container/receptacle by mail and to provide protection and insulation for the container and its specimen content. It can be used for mail services internal or external to healthcare facilities. It includes insulation intended to provide a thermal barrier between the specimen and the environment to preserve temperature-sensitive samples. The device is also intended to protect the specimen container (e.g., glass vial, bottle, tube, or slide) from adverse conditions that could cause breakage. This is a single-use device. | No | Active |
| 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 | 00860004093008 | GS1 |
Customer Contacts
- Phone
- (800) 453-6948
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Refrigerate entire contents at +2 to +8°C (+36 to +46°F)
- Type
- Special Storage Condition, Specify
- Special Conditions
- Refrigerate the two 50 mL plastic screw-top biopsy tubes inside the plastic screw-top cylinder
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not freeze biopsy kit or contents
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not remove the two 50 mL plastic screw-top biopsy tubes from the plastic screw-top cylinder until the time of procedure
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not discard shipping box and components. Shipping box will be used to transport biopsy back to Vericel Corporation at 64 Sidney Street, Cambridge, MA 02139