FDA UDI
In Commercial Distribution
🇺🇸 United States
Reaction vessel
DI: 06925912708513
·
Model: C6100
·
Shenzhen YHLO Biotech Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2000
Basic Information
- Brand Name
- Reaction vessel
- Primary DI
- 06925912708513
- Version / Model
- C6100
- Company Name
- Shenzhen YHLO Biotech Co., Ltd.
- Labeler DUNS
- 420735989
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2000
- Record Status
- Published
- Publish Date
- 2022-10-26
- Public Version
- 1
- Public Version Date
- 2022-11-03
- Public Version Status
- New
- Public Device Record Key
- 17bbf3b8-67ff-4b31-a764-67484ca71604
Device Description
2000 pcs/box (2 bag/box, 1000 pcs/bag)
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
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JRI | Cuvette, Thermostated | Clinical Chemistry | 862.2050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61032 | Laboratory analyser cuvette IVD, single-use | A small volume, rectangular column designed to contain a clinical specimen, reagent, or other material for in vitro diagnostic testing procedures performed by a laboratory analyser. It is transparent to allow light to travel through the contained material and is typically made of plastic, glass or quartz with a flat base and an open top. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 06925912708506 | GS1 | ||||
| Primary | 06925912708513 | GS1 |