FDA UDI
In Commercial Distribution
🇺🇸 United States
KBMED
DI: 00810100050528
·
Model: CTPP15
·
KB Medical (group), Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- KBMED
- Primary DI
- 00810100050528
- Version / Model
- CTPP15
- Company Name
- KB Medical (group), Inc.
- Labeler DUNS
- 105002071
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-22
- Public Version
- 1
- Public Version Date
- 2025-05-30
- Public Version Status
- New
- Public Device Record Key
- 1af04cec-bf6c-4833-893e-337e2d04bb84
Device Description
CENTRIFUGE TUBE, PP 15ML, PACK OF 100
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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 |
|---|---|---|---|---|
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Clinical Chemistry | 862.2050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43761 | Centrifuge tube IVD | A tube intended to be used in the laboratory to contain a clinical specimen, reagent, or other material associated with in vitro diagnostic testing, for separation by centrifugation. It is designed to be placed in a centrifuge rotor for the procedure; it may also be placed in a rack for short-term storage of its contents. It is typically transparent to facilitate observation of its contents, frequently includes a cap (e.g., screw or press-fit), and may have graduations along the side. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10810100050525 | GS1 | CASE | 24 | In Commercial Distribution | |
| Primary | 00810100050528 | GS1 |