Identity
- Trade Name
- Laryngeal Mask Airways FDA UDI
- Generic Name
- Reinforced laryngeal mask airway, single-use FDA UDI
- Device Name
- Laryngeal Mask Airways, Silicone Reinforced, 1.0 mm, Sterile FDA UDI
- Model / Reference
- 5032 FDA UDI
- Description
- Laryngeal Mask Airways, Silicone Reinforced, 1.0 mm, Sterile FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00616784503233 FDA UDI
- FDA Product Code
- CAE FDA UDI
- GMDN Term
- Reinforced laryngeal mask airway, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5110 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Reinforced laryngeal mask airway, single-use
Laryngeal Mask Airways by Dynarex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Reinforced laryngeal mask airway, single-use.
- MICROTEK — Microtek Medical LLC · Class II
- Resp-O2 Laryngeal Mask Airways Silicone Reinforced, Size 2.0 mm — Dynarex Corp. · Class I
- Resp-O2 Laryngeal Mask Airways Silicone, Non-Reinforced, Size 5.0 mm — Dynarex Corp. · Class I
- Laryngeal Mask Airways — Dynarex Corp. · Class I
- Laryngeal Mask Airways — Dynarex Corp. · Class I
- Resp-O2 Laryngeal Mask Airways Silicone Reinforced, Size 4.0 mm — Dynarex Corp. · Class I
- Laryngeal Mask Airways — Dynarex Corp. · Class I
- Resp-O2 Laryngeal Mask Airways Silicone, Non-Reinforced, 2.5 mm — Dynarex Corp. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Dynarex Corp.
Sources (1)
- FDA UDI 471f076c-bc75-4f93-986b-7fe1de03318d 33 fields · synced May 29, 2026