Identity
- Trade Name
- PAS Tubing Kit EUDAMEDDisposables Kit FDA UDI
- Generic Name
- Speech assistive training device FDA UDI
- Device Name
- Intra‑Oral Tubes EUDAMED6650 Disposables Kit (MU0P00000983)(Accessory for PAS 6600) FDA UDI
- Model / Reference
- 6650 EUDAMEDFDA UDI6611 EUDAMED
- Description
- 6650 Disposables Kit (MU0P00000983)(Accessory for PAS 6600) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04961333255986 EUDAMEDFDA UDI
- Basic UDI-DI
- 496133303A6611V6 EUDAMED
- FDA Product Code
- KLX FDA UDI
- EMDN Code
- Z12149080 VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Speech assistive training device FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 874.1325 FDA UDI
- Market of Registration
- Germany 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
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Speech assistive training device
Disposables Kit by PENTAX of America, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- PENTAX of America, Inc.
Sources (2)
- FDA UDI 63eb6374-5814-4642-b7c1-791bb7336a72 33 fields · synced Jun 20, 2026
- EUDAMED 84052530-85c8-4170-b275-42d408c40365 61 fields · synced Jun 20, 2026