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E-A-Rlink™

FDA UDI

Class I (US FDA UDI)

by 3m Company

Identity

Trade Name
E-A-RLINK™ FDA UDI
Generic Name
Audiometric ear tip FDA UDI
Device Name
3M(TM) E-A-RLINK(TM) Foam plug-with-hole 1/2 inch height, 0.100 in hole 5C 420-2036, 10,000/case FDA UDI
Model / Reference
420-2036 FDA UDI
Description
3M(TM) E-A-RLINK(TM) Foam plug-with-hole 1/2 inch height, 0.100 in hole 5C 420-2036, 10,000/case FDA UDI

Identifiers

Catalog Number
420-2036 FDA UDI
Primary DI / UDI-DI
10080529191363 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

E-A-Rlink™ by 3m Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Audiometric ear tip.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
3m Company

Sources (1)

  • FDA UDI 2de8650b-03cf-4f88-8fab-790b6f516cff 35 fields · synced May 31, 2026