Identity
- Trade Name
- O2 Kit FDA UDI
- Generic Name
- Oxygen administration kit FDA UDI
- Device Name
- This kit contains: 3 RES1107S Soft Adult O2 Cannula with 7ft Tubing, 2 RES3025G Oxygen Tubing — 25ft — Green, 2 RES018 Tubing Connector with Swivel, 2 RES03 Oxygen In Use Sign. FDA UDI
- Model / Reference
- ASIM004RESO2KIT FDA UDI
- Description
- This kit contains: 3 RES1107S Soft Adult O2 Cannula with 7ft Tubing, 2 RES3025G Oxygen Tubing — 25ft — Green, 2 RES018 Tubing Connector with Swivel, 2 RES03 Oxygen In Use Sign. FDA UDI
Identifiers
- Catalog Number
- ASIM004RESO2KIT FDA UDI
- Primary DI / UDI-DI
- 00848530084165 FDA UDI
- GMDN Term
- Oxygen administration kit FDA UDI
Classification
- 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
Yes
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
No
FDA UDI
Category: Oxygen administration kit
O2 Kit by SUNSET HEALTHCARE SOLUTIONS, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Medline — MEDLINE INDUSTRIES, INC. · Class I
- SH 74-C Barbed Tubing Adapter — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class I
- MedSource Life Support Kit — MEDSOURCE INTERNATIONAL LLC
- HUDSON RCI — MEDLINE INDUSTRIES, INC. · Class I
- Composite Respiratory Kit — WESTMED, INC. · Class II
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- SUNSET HEALTHCARE SOLUTIONS, Inc.
Sources (1)
- FDA UDI 94b2e3ef-056c-4de9-9fd9-45de2741ee26 35 fields · synced May 30, 2026