FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Sealing Putty for hematocrit capillaries
DI: 04050674019262
·
Model: 2077
·
Andreas Hettich GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
3
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Basic Information
- Brand Name
- Sealing Putty for hematocrit capillaries
- Primary DI
- 04050674019262
- Version / Model
- 2077
- Catalog Number
- 2077
- Company Name
- Andreas Hettich GmbH
- Labeler DUNS
- 316403245
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 5
- Public Version Date
- 2026-01-22
- Public Version Status
- Update
- Public Device Record Key
- d2a51801-981b-4a43-a23e-3f554ebafbbc
- Distribution End Date
- 2017-12-18
Device Description
Sealing putty for capillaries
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
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Primary | 04050674019262 | GS1 | ||||
| Unit of Use | 04050674084802 | GS1 |