FDA UDI
In Commercial Distribution
🇺🇸 United States
VitaVitro
DI: 06971982050007
·
Model: Jd-1.0
·
Shenzhen Vitavitro Bio-Tech Co.,Ltd
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VitaVitro
- Primary DI
- 06971982050007
- Version / Model
- Jd-1.0
- Catalog Number
- V003001, V003002
- Company Name
- Shenzhen Vitavitro Bio-Tech Co.,Ltd
- Labeler DUNS
- 544504573
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-12-05
- Public Version
- 3
- Public Version Date
- 2021-02-22
- Public Version Status
- Update
- Public Device Record Key
- 70d4b20c-97fd-4e0d-8b97-a7ecec267ae6
- Distribution End Date
- 2026-12-05
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
- 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 |
|---|---|---|---|---|
| MQL | Media, Reproductive | Obstetrics/Gynecology | 884.6180 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47445 | Assisted reproduction vitrification kit | A collection of reusable/consumable devices used for the vitrification (cryopreservation) and recovery of biological specimens (e.g., eggs, embryos) in assisted reproduction procedures. It is typically used by embryologists/medical scientists to perform ultra-rapid cooling of a specimen without immersion/contact of the specimen with liquid nitrogen (LN2), and enables subsequent warming to recover the specimen. It typically consists of a highly-conductive metal block with surfaces/slots used for the vitrification process, a cryobath for the LN2 in which the block is placed, plastic carriers to hold and store the specimen, and pipetting devices. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06971982050007 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K180073 | 000 |