EZCare Softouch - Pink N9109PK

GUDID 00812594012228

Trach Holder 9" - Pink

NEOTECH PRODUCTS, INC.

Tracheostomy tube neck holder, reusable

• Primary Device ID: 00812594012228
• NIH Device Record Key: 3be9b8a7-8c80-463f-bf52-97130af58f75
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EZCare Softouch - Pink
• Version Model Number: 10812594012225
• Catalog Number: N9109PK
• Company DUNS: 198013435
• Company Name: NEOTECH PRODUCTS, INC.
• Device Count: 20
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812594012228 [Unit of Use]
GS1	10812594012225 [Primary]

FDA Product Code

• CBH: Device, Fixation, Tracheal Tube

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: 2021-06-23
• Device Publish Date: 2021-06-15

On-Brand Devices [EZCare Softouch - Pink]

• 00812594012181: Trach Holder 5" Pink
• 00812594012242: Trach Holder 11" - Pink
• 00812594012235: Trach Holder 10" - Pink
• 00812594012228: Trach Holder 9" - Pink
• 00812594012211: Trach Holder 8" - Pink
• 00812594012204: Trach Holder 7" - Pink
• 00812594012198: Trach Holder 6" - Pink