DEVICE: E-A-RLINK™ (00080529191274)

Device Identifier (DI) Information

E-A-RLINK™
420-2086
In Commercial Distribution
420-2086
3M COMPANY
00080529191274
GS1

5000
078763316 *Terms of Use
3M(TM) E-A-RLINK(TM) 3A Foam Eartip adult size, yellow, with black tube 420-2086, 5,000/case
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Audiometric ear tip A non-sterile luminal device intended to be connected to the distal end of an audiometric sound delivery tube and inserted into the ear canal, to allow test sounds to be delivered to the ear in isolation from background noise. It is designed to create a seal inside the ear canal whilst allowing the sound tube to pass through the lumen. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
ETT CUSHION, EARPHONE (FOR AUDIOMETRIC TESTING)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

f14f80e2-3f32-47fa-8d0b-8e5bbc0cd151
March 29, 2018
2
September 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: 00051131273290 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(888)733-4512
3Mhealthcarecompliance@mmm.com
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