FDA UDI
In Commercial Distribution
🇺🇸 United States
Newborn Stem Cell Collection Kit International Kit
DI: 00861880000364
·
Model: International Kit
·
CRYO-CELL INTERNATIONAL, INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Newborn Stem Cell Collection Kit International Kit
- Primary DI
- 00861880000364
- Version / Model
- International Kit
- Company Name
- CRYO-CELL INTERNATIONAL, INC.
- Labeler DUNS
- 626132575
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-18
- Public Version
- 1
- Public Version Date
- 2019-09-26
- Public Version Status
- New
- Public Device Record Key
- a8863f97-876c-4381-9d94-3fe6610f69dc
Device Description
Newborn Stem Cell Collection Kit for International collection usage.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47115 | Umbilical cord blood collection set | A group of devices intended to be used to collect, process, and store umbilical cord blood and/or umbilical cord blood components (e.g., buffy coat). It typically includes tubing, hollow needles for insertion into the umbilical cord (a double venipuncture of the cord) to collect the blood, and several containers (flexible bags usually containing an anticoagulant) intended for transitional (room temperature) or long-term (frozen) blood storage. The cord blood is usually intended to be frozen and stored, typically to preserve stem cells, for subsequent reinfusion into patients, generally in cases of leukaemia. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00861880000364 | GS1 |
Customer Contacts
- Phone
- 8137492188
- [email protected]