Identity
- Trade Name
- Oxygen Kit FDA UDI
- Generic Name
- Oxygen administration kit FDA UDI
- Model / Reference
- AACC013OXYGENKITC FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848530098940 FDA UDI
- GMDN Term
- Oxygen administration kit FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Oxygen administration kit
Here is a concise, professional 2-sentence SEO-friendly product description for the 'Oxygen Kit':
"Our Oxygen Kit is designed to provide safe and efficient oxygen administration for single-use purposes, featuring a range of devices including masks, nasal cannulas, oxygen tubing, and humidifiers, all in one convenient kit. Manufactured by SUNSET HEALTHCARE SOLUTIONS, INC., this device complies with standard safety and labeling guidelines."
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
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SUNSET HEALTHCARE SOLUTIONS, Inc.
Sources (1)
- FDA UDI 6b6d50a7-e170-42de-b6d7-14e229950d94 33 fields · synced Jun 19, 2026