Identity
- Trade Name
- HELiOS 36 FDA UDI
- Generic Name
- Portable liquid oxygen unit FDA UDI
- Device Name
- Base Liquid Oxygen Respiratory Equipment, Top Fill, 10 LPM, 20 PSI FDA UDI
- Model / Reference
- B-702100-00 FDA UDI
- Description
- Base Liquid Oxygen Respiratory Equipment, Top Fill, 10 LPM, 20 PSI FDA UDI
Identifiers
- Primary DI / UDI-DI
- M766B702100000 FDA UDI
- 510(k) Number
- K860937 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
HELiOS 36 by Caire Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — 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
K860937 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Caire Inc.
Sources (2)
- FDA UDI aebdce04-3f66-4661-9dda-b1a17b78eedb 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026