Identity
- Trade Name
- MOUTHPIECE (NON CE) FDA UDI
- Generic Name
- Anaesthesia face mask, reusable FDA UDI
- Device Name
- MOUTHPIECE (NON CE) FDA UDI
- Model / Reference
- 61988000 FDA UDI
- Description
- MOUTHPIECE (NON CE) FDA UDI
Identifiers
- Catalog Number
- 61988000 FDA UDI
- Primary DI / UDI-DI
- 00816711022121 FDA UDI
- FDA Product Code
- BYP FDA UDI
- GMDN Term
- Anaesthesia face mask, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5620 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Anaesthesia face mask, reusable
Mouthpiece (non Ce) by Parker Hannifin Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anaesthesia face mask, reusable.
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- AincA® — Anesthesia Associates, Inc. · Class I
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- AincA® — Anesthesia Associates, Inc. · Class I
- Anesthesia Face Mask Pre-Filled Inflatable Single Use Large Adult Size 5 — FLEXICARE MEDICAL LIMITED · Class I
- AincA® — Anesthesia Associates, Inc. · Class I
- O-Two — O-Two Medical Technologies Inc · Class I
- AincA® — Anesthesia Associates, Inc. · 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
- Parker Hannifin Corp.
Sources (1)
- FDA UDI db2e498d-07fb-4c1d-82f1-0ae7ba65ca5b 34 fields · synced May 30, 2026