Mouthpiece, Reusable, Blue Thermoplastic 7/8" I.D.
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Reusable Rubber Mouthpiece EUDAMEDMouthpiece, Reusable, Blue Thermoplastic 7/8" I.D. FDA UDI
- Generic Name
- Breathing mouthpiece, reusable FDA UDI
- Device Name
- Reusable Rubber Mouthpiece and Components EUDAMEDMouthpiece, Reusable, Blue Thermoplastic 7/8" I.D. FDA UDI
- Model / Reference
- Reusable Rubber Mouthpiece and Components EUDAMED164500 EUDAMEDMouthpiece, Reusable 7/8" I.D. - 164500 FDA UDI
- Description
- Mouthpiece, Reusable, Blue Thermoplastic 7/8" I.D. FDA UDI
Identifiers
- Catalog Number
- 164500 FDA UDI
- Primary DI / UDI-DI
- 00817081022810 EUDAMEDFDA UDI
- Basic UDI-DI
- 081708102164XXXLF EUDAMED
- FDA Product Code
- BYP FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Breathing mouthpiece, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.5620 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Breathing mouthpiece, reusable
Mouthpiece, Reusable, Blue Thermoplastic 7/8" I.D. by A-M Systems, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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
- A-M Systems, Inc.
Sources (2)
- FDA UDI f95e174c-c3e8-4dd5-aa9e-f750bb77488a 35 fields · synced Jul 21, 2026
- EUDAMED 1b70052b-4e96-41bb-9f32-5ec1b53cd449 61 fields · synced Jul 21, 2026