FDA UDI
In Commercial Distribution
🇺🇸 United States
LW Scientific, Inc.
DI: 00664816003671
·
Model: CNP-04CC-PR77
·
LW SCIENTIFIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LW Scientific, Inc.
- Primary DI
- 00664816003671
- Version / Model
- CNP-04CC-PR77
- Company Name
- LW SCIENTIFIC, INC.
- Labeler DUNS
- 785335381
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-01-22
- Public Version
- 1
- Public Version Date
- 2020-01-30
- Public Version Status
- New
- Public Device Record Key
- 57c85346-f605-4c16-8624-5c8955a36430
Device Description
Crit Carrier; pair of 4-place hematocrit tube carriers, includes EZ Reader Card
Device Characteristics
- Single Use
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GHY | Hematocrit, Tube, Rack, Sealer, Holder | Hematology | 864.6400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35554 | Centrifuge bucket/tube holder adaptor | A device intended to compensate for and enable the use of different size test tubes and bottles in a centrifuge rotor bucket or centrifuge tube holder. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00664816003671 | GS1 |