Identity
- Trade Name
- PATIENT OXYGEN KIT FDA UDI
- Generic Name
- Oxygen administration kit FDA UDI
- Device Name
- (1) RES031, (1) RES001, (2) RES012, (2) RES1107, (1) RES3025G, (1) RES003 FDA UDI
- Model / Reference
- APAT003O2KIT FDA UDI
- Description
- (1) RES031, (1) RES001, (2) RES012, (2) RES1107, (1) RES3025G, (1) RES003 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848530093259 FDA UDI
- FDA Product Code
- CAT FDA UDI
- GMDN Term
- Oxygen administration kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5340 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
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
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
Patient Oxygen Kit by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Oxygen administration kit.
- MedSource Life Support Kit — MEDSOURCE INTERNATIONAL LLC
- Composite Respiratory Kit: Performance Home Medical — WESTMED, INC. · Class II
- RUSCH — TELEFLEX INCORPORATED · Class I
- 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 | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SUNSET HEALTHCARE SOLUTIONS, Inc.
Sources (1)
- FDA UDI 79727f6f-b502-40d9-95b4-63990f391d00 34 fields · synced Jun 1, 2026