Identity
- Trade Name
- Level 1 FDA UDI
- Generic Name
- Non-respiratory device ambient air filter FDA UDI
- Model / Reference
- L1-FILTER FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15019517100303 FDA UDI
- 510(k) Number
- K181699 FDA UDI
- FDA Product Code
- DWJ FDA UDI
- GMDN Term
- Non-respiratory device ambient air filter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5900 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Non-respiratory device ambient air filter
Level 1 by Icu Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Non-respiratory device ambient air filter.
- AESCULAP — AESCULAP, INC. · Class I
- Coda® — LifeGlobal Group, LLC · Class II
- Coda® — LifeGlobal Group, LLC · Class II
- ChemoPlus — Cardinal Health 200, LLC · Class II
- pNeuton — AIRON CORPORATION · Class II
- Carex — COMPASS HEALTH BRANDS CORP. · Class II
- Pentair — Pentair Filtration Solutions · Class II
- Coda® — LifeGlobal Group, LLC · Class II
Cleared under the same submission
K181699 also covers:
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
- Icu Medical, Inc.
Sources (1)
- FDA UDI 073058ae-44a4-45b6-bf5a-a1efde1e9fdc 33 fields · synced May 30, 2026