Identity
- Trade Name
- Level 1 FDA UDI
- Generic Name
- Intravenous pressure infusor, automated FDA UDI
- Model / Reference
- 7204018 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 50695085800222 FDA UDI
- FDA Product Code
- CAF FDA UDIBSY FDA UDI
- GMDN Term
- Intravenous pressure infusor, automated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5630 FDA UDI868.6810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Intravenous pressure infusor, automated
Level 1 by Icu Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intravenous pressure infusor, automated.
- CORE DYNAMICS — Conmed Corporation · Class II
- CONMED — Conmed Corporation · Class II
- CONMED — Conmed Corporation · Class II
- CONTEC — Contec Medical Systems Co., Ltd. · Class I
- automatic pressure infusor — Biegler GmbH · Class I
- bcI — ICU MEDICAL, INC. · Class II
- Level 1 — ICU MEDICAL, INC. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Icu Medical, Inc.
Sources (1)
- FDA UDI a02191fa-3503-4b28-bdad-be51b82a7f22 32 fields · synced May 30, 2026