FDA UDI
In Commercial Distribution
🇺🇸 United States
Rotor 24 place for capillaries
DI: 04050674030427
·
Model: 1023
·
Andreas Hettich GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Rotor 24 place for capillaries
- Primary DI
- 04050674030427
- Version / Model
- 1023
- Catalog Number
- 1023
- Company Name
- Andreas Hettich GmbH & Co. KG
- Labeler DUNS
- 316403245
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2022-06-10
- Public Version Status
- Update
- Public Device Record Key
- d932172b-2808-4f20-8e72-cd43568b6ccb
Device Description
Hematocrit rotor, 24-place
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| JPI | Device, Hematocrit Measuring | Hematology | 864.6400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32429 | Microhaematocrit centrifuge IVD | An electrically-powered device intended to be used for the processing of whole blood specimens using centrifugal force to determine the haematocrit, i.e., the ratio of red blood cell volume to whole blood volume expressed as a decimal, fraction, or percentage. The device typically requires a smaller sample volume than conventional centrifuges (macrohaematocrit method). The haematocrit is typically used to diagnose blood loss and erythrocyte count above or below normal. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04050674030427 | GS1 |