FDA UDI
In Commercial Distribution
🇺🇸 United States
Sunmed disposable angio-closure pads
DI: 06947358582618
·
Model: Large Size
·
Sunny Medical Device (Shenzhen) Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sunmed disposable angio-closure pads
- Primary DI
- 06947358582618
- Version / Model
- Large Size
- Company Name
- Sunny Medical Device (Shenzhen) Co., Ltd.
- Labeler DUNS
- 529639795
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-06
- Public Version
- 1
- Public Version Date
- 2023-07-14
- Public Version Status
- New
- Public Device Record Key
- 30761c2e-a6bd-4150-b137-d40ce1fa8992
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
- 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 |
|---|---|---|---|---|
| DXC | Clamp, Vascular | Cardiovascular | 870.4450 | 2 |
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 | 06947358582618 | GS1 |