Identity
- Trade Name
- Insitu - ONTRAC PTCA Endoflator FDA UDI
- Generic Name
- Catheter/overtube balloon inflator, single-use FDA UDI
- Device Name
- Inflation Device: 20mL, 30atm FDA UDI
- Model / Reference
- QL® 2030 FDA UDI
- Description
- Inflation Device: 20mL, 30atm FDA UDI
Identifiers
- Catalog Number
- 21000-30 FDA UDI
- Primary DI / UDI-DI
- 00856877002582 FDA UDI
- FDA Product Code
- MAV FDA UDI
- GMDN Term
- Catheter/overtube balloon inflator, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1650 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Insitu - ONTRAC PTCA Endoflator by Atrion Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Atrion Medical Products, Inc.
Sources (1)
- FDA UDI 016e7910-12dc-4c96-bad4-887a18f3fd9f 36 fields · synced Jun 12, 2026