Identity
- Trade Name
- LMA® Fastrach™ Single-Use Airway Size 3 EUDAMEDLMA AIRWAY MANAGEMENT FDA UDI
- Generic Name
- Laryngeal mask airway, single-use FDA UDI
- Device Name
- LMA Fastrach SU EUDAMEDLMA® Fastrach™ Single-Use Airway Size 3 FDA UDI
- Model / Reference
- 135130 EUDAMEDIPN923655 FDA UDI
- Description
- LMA® Fastrach™ Single-Use Airway Size 3 FDA UDI
Identifiers
- Catalog Number
- 135130 FDA UDI
- Primary DI / UDI-DI
- 15060112319393 EUDAMEDFDA UDI
- Basic UDI-DI
- 08019020000000000000139KQ 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 7d0d79d0-64e6-4efd-aa2f-4cc9ea5a0699 37 fields · synced Jun 19, 2026
- EUDAMED 24177f73-35b8-4828-a85f-70f5f5d5f47c 61 fields · synced Jun 19, 2026