FDA UDI
In Commercial Distribution
🇺🇸 United States
GCB Medical Supply
DI: 00850061859655
·
Model: GCBIVT006
·
GCB MEDICAL LLC
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- GCB Medical Supply
- Primary DI
- 00850061859655
- Version / Model
- GCBIVT006
- Catalog Number
- GCBIVT006
- Company Name
- GCB MEDICAL LLC
- Labeler DUNS
- 086699722
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-27
- Public Version
- 1
- Public Version Date
- 2025-03-07
- Public Version Status
- New
- Public Device Record Key
- 3e5ff557-75df-447a-9dd8-20d0aa2b0e3f
Device Description
GCB MEDICAL WIDE NECK ACCESS HOLDER MALE
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
- Yes
- 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 | 00850061859679 | GS1 | Inner Box | 60 | In Commercial Distribution | |
| Primary | 00850061859655 | GS1 | ||||
| Package | 00850061859778 | GS1 | Case | 4 | In Commercial Distribution |
Customer Contacts
- Phone
- (833) 422-6331
- [email protected]