FDA UDI
In Commercial Distribution
🇺🇸 United States
KBMED
DI: 10850016172676
·
Model: NH01
·
KB Medical (group), Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
200
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Basic Information
- Brand Name
- KBMED
- Primary DI
- 10850016172676
- Version / Model
- NH01
- Company Name
- KB Medical (group), Inc.
- Labeler DUNS
- 105002071
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 200
- 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
- d04c9154-cb6e-4503-8377-309415157fe9
Device Description
Tube Holder, Pack of 200pcs
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 |
|---|---|---|---|---|
| KST | System, Blood Collection, Vacuum-Assisted, Manual | Hematology | 864.9125 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37566 | Blood collection tube holder, single-use | A hand-held cylindrical device designed to be used together with an evacuated blood collection tube to draw blood samples from a patient. It is typically a hollow plastic adaptor into which the blood collection tube is inserted and to which the user attaches a hypodermic blood collection needle (not included); it may include an integrated blood collection tube spike. This device also facilitates a multiple-tube blood collection via one venipuncture. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20850016172673 | GS1 | CASE | 4 | In Commercial Distribution | |
| Primary | 10850016172676 | GS1 | ||||
| Unit of Use | 00850016172679 | GS1 |