Berman Airway Length 5cm Size 00
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Berman Airway Length 5cm Size 00 FDA UDI
- Generic Name
- Oropharyngeal airway, single-use FDA UDI
- Device Name
- Oropharyngeal Airways EUDAMED
- Model / Reference
- 038-90-050U EUDAMEDFDA UDIBerman EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055788736318 EUDAMEDFDA UDI
- Basic UDI-DI
- 5055788700030B01JN EUDAMED
- FDA Product Code
- CAE FDA UDI
- EMDN Code
- R010199 NASO-OROPHARYNGEAL TUBES - OTHER EUDAMED
- GMDN Term
- Oropharyngeal airway, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5110 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Oropharyngeal airway, single-use
Berman Airway Length 5cm Size 00 by Flexicare Medical Limited — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Oropharyngeal airway, single-use.
- EVER READY FIRST AID — XIAMEN COMPOWER MEDICAL TECH. CO., LTD · Class I
- SunMed — SunMed · Class I
- TRACHEOSTOMY and SUCTION ACCESSORY — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- SunMed — SunMed · Class I
- Guedel Airways (color coded) — MERCURY ENTERPRISES, INC. · Class I
- RUSCH — TELEFLEX INCORPORATED · Class I
- RUSCH — TELEFLEX INCORPORATED · Class I
- RUSCH — TELEFLEX INCORPORATED · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| 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
- Flexicare Medical Limited
Sources (2)
- FDA UDI b11eb16b-54fc-41ac-92fb-68b75f0e355b 32 fields · synced Oct 11, 2026
- EUDAMED e12e764c-1be7-4cce-a34b-176b6581811b 61 fields · synced Oct 10, 2026