Identity
- Trade Name
- STROLLER FDA UDI
- Generic Name
- Portable liquid oxygen unit FDA UDI
- Device Name
- Portable Liquid Oxygen Respiratory Equipment, Top Fill, 6 LPM, 20 PSI FDA UDI
- Model / Reference
- 11008112 FDA UDI
- Description
- Portable Liquid Oxygen Respiratory Equipment, Top Fill, 6 LPM, 20 PSI FDA UDI
Identifiers
- Primary DI / UDI-DI
- M766110081120 FDA UDI
- 510(k) Number
- K800742 FDA UDI
- FDA Product Code
- BYJ FDA UDI
- GMDN Term
- Portable liquid oxygen unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5655 FDA UDI
- 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
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Portable liquid oxygen unit
Stroller by Caire Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Portable liquid oxygen unit.
- Portable Therapeutic Liquid Oxygen System — Essex Industries, Inc. · Class II
- SPRINT — CAIRE INC. · Class II
- STROLLER — CAIRE INC. · Class II
- Stroller — CAIRE INC. · Class II
- STROLLER — CAIRE INC. · Class II
- STROLLER — CAIRE INC. · Class II
- Spirit Portable Liquid Oxygen — CAIRE INC. · Class II
- Spirit Portable Liquid Oxygen — CAIRE INC. · Class II
Cleared under the same submission
K800742 also covers:
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
- Caire Inc.
Sources (1)
- FDA UDI e7629ec1-9f54-408d-bea5-583e6935be1b 34 fields · synced Jun 8, 2026