Identity
- Trade Name
- CARDINAL HEALTH FDA UDI
- Generic Name
- Insulin syringe/needle, basic FDA UDI
- Model / Reference
- ED052905IN FDA UDI
Identifiers
- Catalog Number
- ED052905IN FDA UDI
- Primary DI / UDI-DI
- 15019517065565 FDA UDI
- 510(k) Number
- K063755 FDA UDI
- FDA Product Code
- MEG FDA UDI
- GMDN Term
- Insulin syringe/needle, basic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5860 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
Yes
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: Insulin syringe/needle, basic
Cardinal Health by Icu Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Insulin syringe/needle, basic.
- EasyTouch — MHC Medical Products · Class II
- EasyTouch — MHC Medical Products · Class II
- BH Supplies — ANREL DISTRIBUTION LLC · Class II
- BD Ultra-Fine — BECTON DICKINSON AND COMPANY · Class II
- droplet insulin syringes — HTL STREFA S A · Class II
- Insulin Syringe — Dynarex Corp. · Class II
- LiteTouch — AMITY HOLDINGS, LLC · Class II
- Ultra-Care Insulin Syringe 30G 5/16" 0.5 CC 100 Ct — ARISE MEDICAL LLC · Class II
Cleared under the same submission
K063755 also covers:
- CARDINAL HEALTH — ICU MEDICAL, INC.
- CARDINAL HEALTH — ICU MEDICAL, INC.
- CARDINAL HEALTH — ICU MEDICAL, INC.
- CARDINAL HEALTH — ICU MEDICAL, INC.
- CARDINAL HEALTH — ICU MEDICAL, INC.
- CARDINAL HEALTH — ICU MEDICAL, INC.
- CARDINAL HEALTH — ICU MEDICAL, INC.
- CARDINAL HEALTH — ICU MEDICAL, INC.
- CARDINAL HEALTH — ICU MEDICAL, INC.
- Jelco — ICU MEDICAL, INC.
- Jelco — ICU MEDICAL, INC.
- Jelco — 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 de55f9b1-be14-43dd-9478-3922c14c39ab 35 fields · synced May 29, 2026