FDA UDI
In Commercial Distribution
🇺🇸 United States
KBMED
DI: 10810100050464
·
Model: BCT02SST8.5
·
KB Medical (group), Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
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Basic Information
- Brand Name
- KBMED
- Primary DI
- 10810100050464
- Version / Model
- BCT02SST8.5
- Company Name
- KB Medical (group), Inc.
- Labeler DUNS
- 105002071
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2025-05-21
- Public Version
- 1
- Public Version Date
- 2025-05-29
- Public Version Status
- New
- Public Device Record Key
- 853a8066-2684-4c57-972a-e9018fbe9ac4
Device Description
GEL & CLOT ACTIVATOR TUBE 8.5ML RED CAP
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | Clinical Chemistry | 862.1675 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41128 | Evacuated blood collection tube IVD, clot activator/separator | A glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum, a clot activator, and a separator (e.g., gel) to separate blood serum from cells. It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation (e.g., blood serum chemistry determinations). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20810100050461 | GS1 | CASE | 20 | In Commercial Distribution | |
| Primary | 10810100050464 | GS1 | ||||
| Unit of Use | 00810100050467 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K093910 | 000 |