ONDAMED 001-05-0101

GUDID 00852318007055

ONDAMED Regulator

ONDAMED INC.

Biofeedback system

• Primary Device ID: 00852318007055
• NIH Device Record Key: bae9d9f3-d136-43e4-9a0d-530ab455d245
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ONDAMED
• Version Model Number: 001-05-0101
• Catalog Number: 001-05-0101
• Company DUNS: 841720167
• Company Name: ONDAMED INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 8455340456
• Email: support@ondamed.net

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852318007055 [Primary]

FDA Product Code

• HCC: Device, Biofeedback

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

On-Brand Devices [ONDAMED]

• 00852318007574: ONDAMED Biofeedback System Basic
• 00852318007567: ONDAMED Biofeedback System with Flex
• 00852318007550: ONDAMED Biofeedback System with MA4, MA8 and Flex
• 00852318007543: ONDAMED Biofeedback System with MA8
• 00852318007536: ONDAMED Biofeedback System with MA4
• 00852318007529: ONDAMED Biofeedback System with MA4 and Flex
• 00852318007512: ONDAMED Biofeedback System with MA8 and Flex
• 00852318007505: ONDAMED Biofeedback System with MA4 and MA8
• 00852318007215: ONDAMED Flex Applicator
• 00852318007055: ONDAMED Regulator
• 00852318007048: ONDAMED MA8 Applicator
• 00852318007031: ONDAMED MA4 Applicator
• 00852318007024: ONDAMED Neck Applicator
• 00852318007017: ONDAMED Hand Applicator
• 00852318007000: ONDAMED Main Unit