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Guedel Airway Length 7cm Size 1 with White Bite Block
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 038-91-100U
Identity
- Trade Name
- Guedel Airway Length 7cm Size 1 with White Bite Block FDA UDI
- Generic Name
- Oropharyngeal airway, single-use FDA UDI
- Device Name
- Oropharyngeal Airways EUDAMED
- Model / Reference
- 038-91-100U EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055788736073 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05055788736073 EUDAMED
- FDA Product Code
- CAE FDA UDI
- EMDN Code
- R010102 GUEDEL AIRWAY TUBES 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
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
No
FDA UDI
Category: Oropharyngeal airway, single-use
Guedel Airway Length 7cm Size 1 with White Bite Block by Flexicare Medical Limited — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED
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Also classified as Oropharyngeal airway, single-use.
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- RUSCH — TELEFLEX INCORPORATED · Class I
- RUSCH — TELEFLEX INCORPORATED · Class I
- RUSCH — TELEFLEX INCORPORATED · Class I
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
- Flexicare Medical Limited
Sources (2)
- FDA UDI a848f199-21e9-426a-a806-7547be66050e 32 fields · synced Oct 7, 2026
- EUDAMED 77ee5754-e84b-4e6f-bb7b-6a23af7906a7 61 fields · synced Oct 7, 2026