FDA UDI
In Commercial Distribution
🇺🇸 United States
Mini Compression Bandage
DI: M689HHMCB01010
·
Model: 01
·
Safeguard US Operating, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Mini Compression Bandage
- Primary DI
- M689HHMCB01010
- Version / Model
- 01
- Catalog Number
- HHMCB01
- Company Name
- Safeguard US Operating, LLC
- Labeler DUNS
- 118492643
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-22
- Public Version
- 2
- Public Version Date
- 2023-02-03
- Public Version Status
- Update
- Public Device Record Key
- f262e2a6-b8a3-4033-bd91-2f56e3651d75
Device Description
1ea - sterile compression bandage w/ 4" x 6" pad and 34" elastic wrap
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
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FQM | Bandage, Elastic | General Hospital | 880.5075 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47976 | Femoral artery compression bandage, single-use | A stretchable piece of fabric material intended to provide pressure for haemostasis to a punctured site on a patient having undergone femoral artery catheterization. It can be used as an alternative to direct hand pressure. This device may be T-shaped and constructed to wrap tightly around the patient's hips/thigh typically with a pressure point device inserted beneath it to augment compression. It is typically used following coronary angiography/ventriculography and percutaneous transluminal coronary angioplasty (PTCA); it may be used on brachial and radial arteries or after venipuncture. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M689HHMCB01010 | HIBCC |
Customer Contacts
- Phone
- 855-428-6074
- [email protected]