N/A

GUDID 00846430004726

Probe Tubes

ETYMOTIC RESEARCH, INC.

Audiometric/hearing aid tester Audiometric/hearing aid tester Audiometric/hearing aid tester Audiometric/hearing aid tester Audiometric/hearing aid tester Audiometric/hearing aid tester Audiometric/hearing aid tester Audiometric/hearing aid tester Audiometric/hearing aid tester Audiometric/hearing aid tester Audiometric/hearing aid tester Audiometric/hearing aid tester Audiometric/hearing aid tester Audiometric/hearing aid tester Audiometric/hearing aid tester Audiometric/hearing aid tester Audiometric/hearing aid tester Audiometric/hearing aid tester

• Primary Device ID: 00846430004726
• NIH Device Record Key: c5f7c0f3-e0b6-4fb4-88e5-c74643a7b2e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: ER7-14C-500
• Company DUNS: 115380859
• Company Name: ETYMOTIC RESEARCH, INC.
• Device Count: 500
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846430004726 [Primary]
GS1	00846430005013 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K861113

FDA Product Code

• ETW: Calibrator, Hearing Aid / Earphone And Analysis Systems

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-19

On-Brand Devices [N/A]

• 00084643005257: Jumbo foam eartip (3 pair)
• 00084643005240: Small beige foam eartip (4 pair)
• 00084643005233: Large 3-flange eartip (5 pair)
• 00084643005226: Standard 3-flange (5 pair)
• 00846430005341: Foam 13 mm (adult) ear tip 10/pk sample
• 00846430005310: Electrode Cables (1pair)
• 00846430005280: Hook and Loop Clips
• 00846430005273: Sound delivery tube adapters (10/pk)
• 00846430005266: Standard black foam eartip (5 pair)
• 00846430005211: Various size eartips (156/pk)
• 00846430005204: 10mm foam ear tip 36pk
• 00846430005198: 13mm horn foam ear tip 36pk
• 00846430005075: ER30 Earphone (pair), ER30-18 tubing with adapters, ER13-14 foam ear tips (13mm), ER13-14B foam
• 00846430005068: 10B+ Low Noise Microphone
• 00846430005051: ER3C-50 Insert Earphone (pair) ER3-21 audiometric tubing, ER003452AR foam ear tips (13mm) ER0034
• 00846430005044: ER3C-10 insert earphone (pair) ER3-21 audiometric tubing, ER003452AR foam ear tips (13mm), ER003
• 00846430005006: ER30 Insert Earphones for Special Uses
• 00846430004993: ER-3C Insert Earphone (50 ohm)
• 00846430004986: ER3C-10 Insert Earphone for Audiometry (10 ohm)
• 00846430004849: Impedance tip adapters with striped tubing (1 red, 1 blue)
• 00846430004801: White tube nipples
• 00846430004795: 20' clear silicone tubing with tip adapters
• 00846430004788: Tubing nipples
• 00846430004771: right angle adapter
• 00846430004764: Impedance tip adapters
• 00846430004757: Impedance tip adapters
• 00846430004740: Impedance tip adapters with tubing
• 00846430004733: Impedance tip adapters
• 00846430004726: Probe Tubes
• 00846430004719: Probe Tubes
• 00846430004702: Striped Sound Tubing
• 00846430004696: Solid Color Silicone Sound Delivery Tubing with adapters
• 00846430004689: Striped Sound Tubing 4pk
• 00846430004672: Blue Striped Sound Tubing
• 00846430004665: Striped Sound Tubing 4pk
• 00846430004658: Striped Sound Tubing 500pk
• 00846430004641: Striped SoundTubing 4pk
• 00846430004634: Striped Red Tubing 100pk
• 00846430004610: Tubephone coupling tubes 4pk
• 00846430004580: Frost 3 flange ear tip (pair), 13mm black foam ear tip (pair), Clear 3 flange ear tip (pair), 10
• 00846430004573: Infant silicone ear tip 100pk
• 00846430004566: 4mm PVC ear tip 10pk
• 00846430004559: 4mm PVC ear tip 14pk
• 00846430004542: 4mm PVC ear tip 20pk
• 00846430004535: 18mm foam ear tip 4pk
• 00846430004528: 18mm foam ear tip 2pk
• 00846430004511: 18mm foam ear tip 24pk
• 00846430004504: 3.5mm PVC ear tip 10pk
• 00846430004498: 3.5mm PVC ear tip 14pk
• 00846430004481: 3.5mm PVC ear tip 20pk