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Mouthpiece, Disposable, White, Thermoplastic, Bite Block Style
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Mouthpiece, Disposable, White, Thermoplastic, Bite Block Style FDA UDI
- Generic Name
- Breathing mouthpiece, single-use FDA UDI
- Device Name
- Mouthpiece, Disposable, White, Thermoplastic, Bite Block Style, D R Burton FDA UDI
- Model / Reference
- Disposable Mouthpiece, Bite Block Style - 164904 FDA UDI
- Description
- Mouthpiece, Disposable, White, Thermoplastic, Bite Block Style, D R Burton FDA UDI
Identifiers
- Catalog Number
- 164904 FDA UDI
- Primary DI / UDI-DI
- 00817081028225 FDA UDI
- FDA Product Code
- BYP FDA UDI
- GMDN Term
- Breathing mouthpiece, single-use 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Breathing mouthpiece, single-use
Mouthpiece, Disposable, White, Thermoplastic, Bite Block Style by A-M Systems, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Breathing mouthpiece, single-use.
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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
- A-M Systems, Inc.
Sources (1)
- FDA UDI 66f388d5-9f61-448f-9400-ac641aab6e50 35 fields · synced May 30, 2026