Oticon

GUDID 05707131331694

OPN 3, KIT 10 75 C001

Oticon A/S

In-the-ear air-conduction hearing aid

• Primary Device ID: 05707131331694
• NIH Device Record Key: 9c252244-5dad-48a6-b6ca-eb4adeb9e185
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oticon
• Version Model Number: 182725
• Company DUNS: 305839946
• Company Name: Oticon A/S
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4539177100
• Email: hama@oticon.com
• Phone: +4539177100
• Email: hama@oticon.com
• Phone: +4539177100
• Email: hama@oticon.com
• Phone: +4539177100
• Email: hama@oticon.com
• Phone: +4539177100
• Email: hama@oticon.com
• Phone: +4539177100
• Email: hama@oticon.com
• Phone: +4539177100
• Email: hama@oticon.com
• Phone: +4539177100
• Email: hama@oticon.com
• Phone: +4539177100
• Email: hama@oticon.com
• Phone: +4539177100
• Email: hama@oticon.com
• Phone: +4539177100
• Email: hama@oticon.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05707131331694 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133308

FDA Product Code

• KLW: Masker, tinnitus

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-20
• Device Publish Date: 2018-08-20

On-Brand Devices [Oticon]

• 05711584070123: OPN PLAY 1, MINIRITE T 312 2.4G C047
• 05711584063088: OPN 1, MINIRITE T 312 2.4G C063
• 05711584061343: OPN 1, MINIRITE T 312 2.4G C090
• 05711584058756: SPEAKER UNIT, 4R 100 MINIFIT NEUTRAL
• 05711584058749: SPEAKER UNIT, 4L 100 MINIFIT NEUTRAL
• 05711584058732: SPEAKER UNIT, 3R 100 MINIFIT NEUTRAL
• 05711584058725: SPEAKER UNIT, 3L 100 MINIFIT NEUTRAL
• 05711584058718: SPEAKER UNIT, 2R 100 MINIFIT NEUTRAL
• 05711584058701: SPEAKER UNIT, 2L 100 MINIFIT NEUTRAL
• 05711584058695: SPEAKER UNIT, 1R 100 MINIFIT NEUTRAL
• 05711584058688: SPEAKER UNIT, 1L 100 MINIFIT NEUTRAL
• 05711584058671: SPEAKER UNIT, 4R 85 MINIFIT NEUTRAL
• 05711584058664: SPEAKER UNIT, 4L 85 MINIFIT NEUTRAL
• 05711584058657: SPEAKER UNIT, 3R 85 MINIFIT NEUTRAL
• 05711584058640: SPEAKER UNIT, 3L 85 MINIFIT NEUTRAL
• 05711584058633: SPEAKER UNIT, 2R 85 MINIFIT NEUTRAL
• 05711584058626: SPEAKER UNIT, 2L 85 MINIFIT NEUTRAL
• 05711584058619: SPEAKER UNIT, 1R 85 MINIFIT NEUTRAL
• 05711584058602: SPEAKER UNIT, 1L 85 MINIFIT NEUTRAL
• 05711584058596: SPEAKER UNIT, 4L 60 MINIFIT NEUTRAL
• 05711584058589: SPEAKER UNIT, 4R 60 MINIFIT NEUTRAL
• 05711584058572: SPEAKER UNIT, 3L 60 MINIFIT NEUTRAL
• 05711584058565: SPEAKER UNIT, 3R 60 MINIFIT NEUTRAL
• 05711584058558: SPEAKER UNIT, 2L 60 MINIFIT NEUTRAL
• 05711584058541: SPEAKER UNIT, 2R 60 MINIFIT NEUTRAL
• 05711584058534: SPEAKER UNIT, 1L 60 MINIFIT NEUTRAL
• 05711584058527: SPEAKER UNIT, 1R 60 MINIFIT NEUTRAL
• 05711584052037: DYNAMO SP10, BTE 13 WL 110 SGR
• 05711584052020: SENSEI PRO SP, BTE 13 WL 110 EME
• 05711584025765: RC-P, NEUTRAL KIT TT
• 05711584002452: IN1 ITCD, BE INIZIA 1
• 05711584002445: IN3 ITCD, BE INIZIA 3
• 05711584002438: IN1 CIC, BE INIZIA 1
• 05711584002421: IN3 CIC, BE INIZIA 3
• 05711584002414: IN1 ITC, L BE INIZIA 1
• 05711584002407: IN1 ITC, R BE INIZIA 1
• 05711584002391: IN3 ITC, L BE INIZIA 3
• 05711584002384: IN3 ITC, R BE INIZIA 3
• 05707131357885: OPN PLAY 1, MINIRITE R LI-ION 2.4G C090 DEMO
• 05707131349910: G30 S FW 7.0
• 05707131349903: G40 S FW 7.0
• 05707131349897: G50 S FW 7.0
• 05707131349880: G300 S FW 7.0
• 05707131349873: G400 S FW 7.0
• 05707131349866: G500 S FW 7.0
• 05707131349859: OPN PLAY 2 FW 7.0
• 05707131349842: OPN PLAY 1 FW 7.0
• 05707131349835: OPN S 3 FW 7.0
• 05707131349828: OPN S 2 FW 7.0
• 05707131349811: OPN S 1 FW 7.0