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TEVADAPTOR® Connecting Set with ULTRASITE® Injection Site
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- TEVADAPTOR® Connecting Set with ULTRASITE® Injection Site FDA UDI
- Generic Name
- Basic intravenous administration set, noninvasive FDA UDI
- Device Name
- TEVADAPTOR® Connecting Set with ULTRASITE® Injection Site for use with OnGuardTM contained Medication System FDA UDI
- Model / Reference
- MG412115 FDA UDI
- Description
- TEVADAPTOR® Connecting Set with ULTRASITE® Injection Site for use with OnGuardTM contained Medication System FDA UDI
Identifiers
- Catalog Number
- MG412115 FDA UDI
- Primary DI / UDI-DI
- 27298119121151 FDA UDI
- 510(k) Number
- K141306 FDA UDI
- FDA Product Code
- FPA 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
No
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: Basic intravenous administration set, noninvasive
TEVADAPTOR® Connecting Set with ULTRASITE® Injection Site by Teva Pharmaceutical Industries Limited — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Basic intravenous administration set, noninvasive.
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- ICU Medical — ICU MEDICAL, INC. · Class II
- Kew Medical — DOUGLAS MEDICAL PRODUCTS, INC · Class II
- ICU Medical — ICU MEDICAL, INC. · Class II
Cleared under the same submission
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
- Teva Pharmaceutical Industries Limited
Sources (1)
- FDA UDI 6221a96d-2277-4940-9781-d6951213f248 35 fields · synced May 30, 2026