Identity
- Trade Name
- ICU Medical FDA UDI
- Generic Name
- Vial/bottle adaptor, non-hermetic FDA UDI
- Device Name
- ChemoClave™ Vented Vial Spike, 20mm FDA UDI
- Model / Reference
- AH-70S FDA UDI
- Description
- ChemoClave™ Vented Vial Spike, 20mm FDA UDI
Identifiers
- Catalog Number
- AH-70S FDA UDI
- Primary DI / UDI-DI
- 00887709088382 FDA UDI
- 510(k) Number
- K081361 FDA UDI
- FDA Product Code
- FPA FDA UDI
- GMDN Term
- Vial/bottle adaptor, non-hermetic 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
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
Category: Vial/bottle adaptor, non-hermetic
ICU Medical by Icu Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vial/bottle adaptor, non-hermetic.
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- Vial Adapter — WEST PHARMA. SERVICES IL, . LTD · Class II
- Vial Adapter — WEST PHARMA. SERVICES IL, . LTD · Class II
- Mini-Spike® — B. BRAUN MEDICAL INC. · Class II
- VYGON — Vygon Corp. · Class II
- ViaLok — Yukon Medical, LLC · Class II
- ZYNRELEF 20 mL Vial Access Needle (VAN) — HERON THERAPEUTICS, INC.
- Vial Adaptor — WEST PHARMA. SERVICES IL, . LTD · Class II
Cleared under the same submission
K081361 also covers:
- AMSafe® MicroClave® IV Bag Spike — AMSINO INTERNATIONAL, 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 7a74ee0e-20ed-4668-9158-e25005cb82f2 36 fields · synced Jun 8, 2026