Identity
- Trade Name
- ICU Medical FDA UDI
- Generic Name
- Basic intravenous administration set, noninvasive FDA UDI
- Device Name
- 7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave® Clear, NanoClave®, Clamp, RL FDA UDI
- Model / Reference
- A1007 FDA UDI
- Description
- 7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave® Clear, NanoClave®, Clamp, RL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00887709051041 FDA UDI
- 510(k) Number
- K964435 FDA UDI
- FDA Product Code
- FMG FDA UDI
- GMDN Term
- Basic intravenous administration set, noninvasive FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 FDA UDI
- Commercial Distribution
- 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Basic intravenous administration set, noninvasive
ICU Medical by Icu Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Basic intravenous administration set, noninvasive.
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- IMED — BQ PLUS MEDICAL CO., LTD. · Class II
- Kew Medical — DOUGLAS MEDICAL PRODUCTS, INC · Class II
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- Walrus — CODAN US Corporation · Class II
- NAMIC — NAVILYST MEDICAL, INC. · Class II
- TrueCare Biomedix — U.S. Infusion, LLC · Class II
Cleared under the same submission
K964435 also covers:
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
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 969b0de5-fb5a-4994-befb-5dd34ab7250f 34 fields · synced May 30, 2026