FDA UDI
In Commercial Distribution
🇺🇸 United States
Comfort Band Non-Sterile 14"
DI: 00811331011807
·
Model: CB-7514B
·
Tz Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Comfort Band Non-Sterile 14"
- Primary DI
- 00811331011807
- Version / Model
- CB-7514B
- Company Name
- Tz Medical, Inc.
- Labeler DUNS
- 793149709
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-21
- Public Version
- 1
- Public Version Date
- 2023-09-29
- Public Version Status
- New
- Public Device Record Key
- 971d8a3d-deb1-40d2-97fc-284cc734a573
Device Description
Comfort Band Non-Sterile 14" Blue
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
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MHW | Dressing, Compression | General Hospital | 880.5075 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65119 | Vascular puncture haemostasis arm clamp/band, single-use | A semi-flexible, adjustable, clamp or band/strap device designed for application over an arterial/venous/fistula needle-puncture site on a patient’s arm to provide uniform pressure and achieve haemostasis. Commonly used on haemodialysis patients, some types are referred to as fistula clamps. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00811331011807 | GS1 |