Identity
- Trade Name
- INFANT E-A-RTIP FDA UDI
- Generic Name
- Audiometric ear tip FDA UDI
- Device Name
- 3M(TM) Infant Eartip 3.5mm 420-2094-5, 10 pair/case FDA UDI
- Model / Reference
- 420-2094 FDA UDI
- Description
- 3M(TM) Infant Eartip 3.5mm 420-2094-5, 10 pair/case FDA UDI
Identifiers
- Catalog Number
- 420-2094 FDA UDI
- Primary DI / UDI-DI
- 00080529510105 FDA UDI
- FDA Product Code
- ETT FDA UDI
- GMDN Term
- Audiometric ear tip FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.1100 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
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Audiometric ear tip
Infant E-A-Rtip by 3m Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- 3m Company
Sources (1)
- FDA UDI f5cfd354-ebfb-45dd-b06a-ae424fac9b57 35 fields · synced Jun 8, 2026