← Back to catalogue
Disposable Pressure Infusion Bag
EUDAMEDFDA UDIClass I (EU MDR)
Ref V1010PModel V1005P
Identity
- Trade Name
- Disposable Pressure Infusion Bag EUDAMEDMedCuff FDA UDI
- Generic Name
- Intravenous pressure infusor, automated FDA UDI
- Device Name
- Disposable Pressure Infusion Bag EUDAMEDDisposable Pressure Infusion Bag,mesh back,1000ml FDA UDI
- Model / Reference
- V1005P EUDAMEDV1010P EUDAMEDFDA UDI
- Description
- Disposable Pressure Infusion Bag,mesh back,1000ml FDA UDI
Identifiers
- Primary DI / UDI-DI
- 96973521872067 EUDAMEDFDA UDI
- Basic UDI-DI
- 697352187PIGSQD EUDAMED
- FDA Product Code
- KZD FDA UDI
- EMDN Code
- A088001 PRESSURE INFUSION CUFFS, SINGLE-USE EUDAMED
- GMDN Term
- Intravenous pressure infusor, automated FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5420 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Disposable Pressure Infusion Bag by Vistar Medical Supplies Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697352187PIGSQD | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vistar Medical Supplies Co., Ltd.
- EUDAMED SRN
- CN-MF-000011207
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (2)
- EUDAMED 73e8d382-a1f3-4e7f-a4a1-d2d16f53c25f 61 fields · synced Oct 6, 2026
- FDA UDI d9321b85-23c5-4ab2-8025-eba93a8fb60b 33 fields · synced May 30, 2026