FDA UDI
In Commercial Distribution
🇺🇸 United States
KBMED
DI: 10810100050068
·
Model: SBCN23K-1
·
KB Medical (group), Inc.
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
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Basic Information
- Brand Name
- KBMED
- Primary DI
- 10810100050068
- Version / Model
- SBCN23K-1
- 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
- 0ad53647-e5b0-4803-91ee-f8f2ac69180e
Device Description
SAFETY BLOOD COLLECTION SET, 23G*3/4" with 12" tubing, soft blister, box of 50pcs
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
- Yes
- 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 |
| FMI | Needle, Hypodermic, Single Lumen | General Hospital | 880.5570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58497 | Blood collection set, invasive | A collection of devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a blood collection needle or venous butterfly/scalp vein needle and additional devices that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder. Blood access is directly through the vein with the needle. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20810100050065 | GS1 | CASE | 10 | In Commercial Distribution | |
| Primary | 10810100050068 | GS1 | ||||
| Unit of Use | 00810100050061 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172763 | 000 |