FDA UDI
In Commercial Distribution
🇺🇸 United States
QBC Diagnostics
DI: 00858092006376
·
Model: 429011
·
DRUCKER DIAGNOSTICS
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
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Basic Information
- Brand Name
- QBC Diagnostics
- Primary DI
- 00858092006376
- Version / Model
- 429011
- Catalog Number
- 429011
- Company Name
- DRUCKER DIAGNOSTICS
- Labeler DUNS
- 022156957
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 6
- Public Version Date
- 2023-10-25
- Public Version Status
- Update
- Public Device Record Key
- 36718f36-e209-45df-b87c-7e53b5a781b8
Device Description
QBC STAR Tube - Blood Collection Device (Bag of 20)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| GKZ | Counter, Differential Cell | Hematology | 864.5220 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57892 | Capillary blood collection tube IVD, K2EDTA | A non-sterile glass or plastic collection tube containing the anticoagulant dipotassium ethylene diamine tetraacetic acid (K2EDTA), intended to be used for the collection, preservation and/or transport of capillary blood for analysis or other investigation (e.g., microhaematocrit). It is typically sealed at one or both ends with a putty-like substance following specimen collection, It is This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00858092006376 | GS1 | ||||
| Unit of Use | 00858092006178 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K992849 | 000 |