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Mouthpiece, Reusable, Blue Thermoplastic
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 164000Model Reusable Rubber Mouthpiece and Components
Identity
- Trade Name
- Reusable Rubber Mouthpiece EUDAMEDMouthpiece, Reusable, Blue Thermoplastic FDA UDI
- Generic Name
- Breathing mouthpiece, reusable FDA UDI
- Device Name
- Reusable Rubber Mouthpiece and Components EUDAMEDMouthpiece, Reusable, Blue Thermoplastic FDA UDI
- Model / Reference
- Reusable Rubber Mouthpiece and Components EUDAMED164000 EUDAMEDMouthpiece, Reusable - 164000 FDA UDI
- Description
- Mouthpiece, Reusable, Blue Thermoplastic FDA UDI
Identifiers
- Catalog Number
- 164000 FDA UDI
- Primary DI / UDI-DI
- 00817081022780 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
- Spain 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Breathing mouthpiece, reusable
Mouthpiece, Reusable, Blue Thermoplastic by A-M Systems, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Breathing mouthpiece, reusable.
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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
- A-M Systems, Inc.
Sources (2)
- FDA UDI be38929a-ba87-4182-9ee0-429346664593 35 fields · synced Aug 1, 2026
- EUDAMED 86447bc4-aca2-460b-9b09-f69191b0c772 61 fields · synced Aug 1, 2026