FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Hematocrit capillaries
DI: 04050674084833
·
Model: 2074
·
Andreas Hettich GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- Hematocrit capillaries
- Primary DI
- 04050674084833
- Version / Model
- 2074
- Catalog Number
- 2074
- Company Name
- Andreas Hettich GmbH & Co. KG
- Labeler DUNS
- 316403245
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2020-02-11
- Public Version Status
- Update
- Public Device Record Key
- 31f498bd-a8c5-4d5e-b4a5-c0c048ffbc78
- Distribution End Date
- 2020-02-05
Device Description
Hematocrit capillaries
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| GHY | Hematocrit, Tube, Rack, Sealer, Holder | Hematology | 864.6400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61387 | Capillary blood collection tube IVD, sodium heparin | A non-sterile glass or plastic collection tube containing the anticoagulant sodium heparin, intended to be used for the collection preservation and/or transport of capillary blood for analysis or other investigation (e.g., microhaematocrit, neonatal bilirubin). It is typically sealed at one or both ends with a putty-like substance following specimen collection. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04050674019279 | GS1 | 10 | Not in Commercial Distribution | 2020-02-05 | |
| Primary | 04050674084833 | GS1 | ||||
| Unit of Use | 04050674085045 | GS1 |