FDA UDI
In Commercial Distribution
🇺🇸 United States
MedCuff
DI: 96973521872074
·
Model: V1030P
·
Shenzhen Vistar Medical Supplies Co.,Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MedCuff
- Primary DI
- 96973521872074
- Version / Model
- V1030P
- Company Name
- Shenzhen Vistar Medical Supplies Co.,Ltd.
- Labeler DUNS
- 544328369
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-10-06
- Public Version
- 1
- Public Version Date
- 2021-10-14
- Public Version Status
- New
- Public Device Record Key
- 8952d954-837f-4fd2-851b-434c8cef47c3
Device Description
Disposable Pressure Infusion Bag,mesh back,3000ml
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
- Yes
- 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 |
|---|---|---|---|---|
| KZD | Infusor, Pressure, For I.V. Bags | General Hospital | 880.5420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38468 | Intravenous pressure infusor, automated | A pneumatically-powered device designed to increase the rate of an intravenous (IV) infusion given to a patient by applying pressure directly to the infusion bag. The device is designed with a pressure chamber into which the infusion bag is secured, and is connected to a supply of pressurized air which, when activated, creates pressure in the rear of the chamber. It typically includes a pressure gauge to indicate the applied pressure and overpressure safety features. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 96973521872074 | GS1 |