Identity
- Trade Name
- Pediatric Disposable Masks EUDAMEDPHONATORY AERODYNAMIC SYSTEM FDA UDI
- Generic Name
- Electroglottograph FDA UDI
- Device Name
- Pediatric Disposable Masks EUDAMED30 PEDIATRIC DISPOSABLE MASKS FDA UDI
- Model / Reference
- 6615 EUDAMEDFDA UDI
- Description
- 30 PEDIATRIC DISPOSABLE MASKS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04961333231034 EUDAMEDFDA UDI
- Basic UDI-DI
- 496133303A6615VE EUDAMED
- FDA Product Code
- KLX FDA UDI
- EMDN Code
- Z12149080 VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Electroglottograph 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
Yes
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
No
FDA UDI
Category: Electroglottograph
Phonatory Aerodynamic System by PENTAX of America, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Electroglottograph.
- Two Channel Electroglottograph EG2-PCX2 — Glottal Enterprises, Inc. · Class II
- PHONATORY AERODYNAMIC SYSTEM — PENTAX of America, Inc. · Class II
- ADSV — PENTAX of America, Inc. · Class II
- SONA-SPEECH II — PENTAX of America, Inc. · Class II
- NASOMETER II — PENTAX of America, Inc. · Class II
- REAL-TIME — PENTAX of America, Inc. · Class II
- PHONATORY AERODYNAMIC SYSTEM — PENTAX of America, Inc. · Class II
- NASOMETER II — PENTAX of America, Inc. · Class II
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 34a57d0e-6b37-402e-b3c9-8bf45af87f9a 33 fields · synced Aug 1, 2026
- EUDAMED fc041065-064f-426b-b900-40a3f24c998f 61 fields · synced Aug 1, 2026