Vascular Medical Disposable Inflation Device
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- QL2030PR EUDAMEDVascular Medical Disposable Inflation Device FDA UDI
- Generic Name
- Catheter/overtube balloon inflator, single-use FDA UDI
- Device Name
- QL Inflation Device EUDAMEDInflation Device: 20mL, 30atm FDA UDI
- Model / Reference
- 96470 EUDAMEDQL2030PR FDA UDI
- Description
- Inflation Device: 20mL, 30atm FDA UDI
Identifiers
- Catalog Number
- 96470 FDA UDI
- Primary DI / UDI-DI
- 00856877002452 EUDAMEDFDA UDI
- Basic UDI-DI
- 0856877002QLINFCK EUDAMED
- FDA Product Code
- KOE FDA UDIMAV FDA UDI
- EMDN Code
- A020199 SYRINGES, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Catheter/overtube balloon inflator, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5520 FDA UDI870.1650 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Catheter/overtube balloon inflator, single-use
Vascular Medical Disposable Inflation Device by Atrion Medical Products, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Atrion Medical Products, Inc.
Sources (2)
- FDA UDI 73896bc8-fbb0-4e9a-b71b-783051edcdad 35 fields · synced Oct 6, 2026
- EUDAMED b432e992-ec4e-411f-b4bd-c13bd43d145f 61 fields · synced Sep 17, 2026