Identity
- Trade Name
- LMA® Flexible™ Single-Use Airway Size 3 EUDAMEDLMA AIRWAY MANAGEMENT FDA UDI
- Generic Name
- Laryngeal mask airway, single-use FDA UDI
- Device Name
- LMA Flexible (S) cuff pilot EUDAMEDLMA® Flexible™ Single-Use Airway Size 3 FDA UDI
- Model / Reference
- 115030 EUDAMEDIPN923660 FDA UDI
- Description
- LMA® Flexible™ Single-Use Airway Size 3 FDA UDI
Identifiers
- Catalog Number
- 115030 FDA UDI
- Primary DI / UDI-DI
- 15060112319447 EUDAMEDFDA UDI
- Basic UDI-DI
- 08019020000000000000141KB EUDAMED
- FDA Product Code
- CAE FDA UDI
- EMDN Code
- R01020101 LARYNGEAL MASKS, SINGLE-LUMEN EUDAMED
- GMDN Term
- Laryngeal mask airway, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5110 FDA UDI
- Market of Registration
- 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Laryngeal mask airway, single-use
Lma Airway Management by Teleflex Incorporated — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Laryngeal mask airway, single-use.
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- Laryngeal Mask Airway — HENAN TUOREN MEDICAL DEVICE CO., LTD. · Class IIa
- SourceMark — SOURCEMARK, LLC. · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class I
- Disposable Laryngeal Mask Airway — Rmist(Tianjin) Medical Device Co., Ltd. · Class IIa
- Disposable Laryngeal Mask Airway — ZHEJIANG HAISHENG MEDICAL DEVICE CO., LTD. · Class IIa
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 |
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Manufacturer
- Manufacturer
- Teleflex Incorporated
Sources (2)
- FDA UDI 8df5da68-309e-4a7a-b872-0fa9fc4f5ca6 37 fields · synced Jul 9, 2026
- EUDAMED 49f33aa4-ce1c-420a-8d0c-9f66cdfcb685 61 fields · synced Jul 9, 2026