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FACE TENT WITH AEROSOL 22mm CONNECTOR
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref OM-81312
Identity
- Trade Name
- Face Tent Mask EUDAMEDFACE TENT WITH AEROSOL 22mm CONNECTOR FDA UDI
- Generic Name
- Respiratory oxygen therapy system FDA UDI
- Device Name
- Face Tent with Aerosol 22mm Connector with Elastic Strap EUDAMEDFACE TENT WITH AEROSOL 22mm CONNECTOR FDA UDI
- Model / Reference
- OM-81312 EUDAMEDFDA UDI
- Description
- FACE TENT WITH AEROSOL 22mm CONNECTOR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04716770813127 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04716770813127 EUDAMED
- FDA Product Code
- BYG FDA UDI
- EMDN Code
- R03010301 AEROSOL THERAPY MASKS EUDAMED
- GMDN Term
- Respiratory oxygen therapy system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5580 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Respiratory oxygen therapy system
FACE TENT WITH AEROSOL 22mm CONNECTOR by Besmed Health Business Corp. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Respiratory oxygen therapy system.
- 02-RESQ — Pulmodyne Inc. · Class II
- 02-RESQ — Pulmodyne Inc. · Class II
- GO-PAP — Pulmodyne Inc. · Class II
- O2-RESQ — Pulmodyne Inc. · Class II
- O2-MAX — Pulmodyne Inc. · Class II
- Infant Flow™ — VYAIRE MEDICAL, INC. · Class II
- AincA — Anesthesia Associates, Inc. · Class II
- Infant Flow — VYAIRE MEDICAL, INC. · Class II
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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Besmed Health Business Corp.
Sources (2)
- FDA UDI d10fc2ec-01a1-49a5-853e-f7735e033a7d 33 fields · synced Jul 24, 2026
- EUDAMED 2b7a0267-b045-498b-be99-0082540131f4 61 fields · synced Jul 24, 2026