Identity
- Trade Name
- LMA ProSeal™ Size 4 EUDAMEDLMA AIRWAY MANAGEMENT FDA UDI
- Generic Name
- Laryngeal mask airway, reusable FDA UDI
- Device Name
- LMA PROSEAL EUDAMEDLMA ProSeal™ Size 4 FDA UDI
- Model / Reference
- 150040 EUDAMEDIPN929453 FDA UDI
- Description
- LMA ProSeal™ Size 4 FDA UDI
Identifiers
- Catalog Number
- 150040 FDA UDI
- Primary DI / UDI-DI
- 10801902154108 EUDAMEDFDA UDI
- Basic UDI-DI
- 08019020000000000000100JV EUDAMED
- Direct Marketing DI
- 50801902154106 EUDAMED
- FDA Product Code
- CAE FDA UDI
- EMDN Code
- R01020102 LARYNGEAL MASKS, DOUBLE-LUMEN EUDAMED
- GMDN Term
- Laryngeal mask airway, reusable 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
No
EUDAMEDFDA UDI
Single Use
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Laryngeal mask airway, reusable
Lma Airway Management by Teleflex Incorporated — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 f0b22838-bd81-4859-912c-d188d3ac6d2c 37 fields · synced Jun 19, 2026
- EUDAMED 26ef842e-db9f-4a4d-8980-caffe7452d7d 61 fields · synced Jun 19, 2026