FDA UDI
In Commercial Distribution
🇺🇸 United States
HOC COLLECTION VIAL 30ML
DI: 03700111400863
·
Model: HOC COLLECTION VIAL 30ML
·
LABORATOIRE CCD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- HOC COLLECTION VIAL 30ML
- Primary DI
- 03700111400863
- Version / Model
- HOC COLLECTION VIAL 30ML
- Catalog Number
- 1302001
- Company Name
- LABORATOIRE CCD
- Labeler DUNS
- 381633924
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-05
- Public Version
- 1
- Public Version Date
- 2023-12-13
- Public Version Status
- New
- Public Device Record Key
- ebbf86b1-9336-4160-b786-593ba7681552
Device Description
Device for oocyte collection
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| MQE | NEEDLE, ASSISTED REPRODUCTION | Obstetrics/Gynecology | 884.6100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57834 | Assisted reproduction cryotube | A sterile container (a dedicated sealable tube) intended for transport, storage and preparation of biological samples of human origin used in assisted reproduction techniques (ART), e.g., embryos. It is intended for use in assisted reproduction clinics and is specific to the procedure(s) and policies used in, in vitro fertilization (IVF) and ART clinics. Its main application being to hold biological materials when stored in a frozen state at temperatures below -130 Celsius (e.g., stored in the gas phase above the liquid nitrogen (LN2) at temperatures around -178 C to -150 C). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 03700111425866 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 03700111400863 | GS1 |
Customer Contacts
- Phone
- +33(0)344266394
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 30 | Milliliter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- -The product must not be used in the event of damaged, or open primary packaging before the medical procedure. -Store away from direct sunlight. -Store in a dry place.