EZCare Softouch - 5" Blue (N9105BL) N9105BL

GUDID 10812594012324

Neotech Products LLC

Tracheostomy tube neck holder, reusable

• Primary Device ID: 10812594012324
• NIH Device Record Key: f80425cf-efff-4d42-8dc1-11f4dbcdac01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EZCare Softouch - 5" Blue (N9105BL)
• Version Model Number: 10812594012324
• Catalog Number: N9105BL
• Company DUNS: 198013435
• Company Name: Neotech Products LLC
• 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: false
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812594012327 [Unit of Use]
GS1	00812594012969 [Unit of Use]
GS1	10812594012324 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-07-26
• Device Publish Date: 2017-04-07

Devices Manufactured by Neotech Products LLC

• 10812594013239 - NeoSnug Micro: 2024-10-22 NeoSnug is intended to support, secure, and hold gastrointestinal tubes on patients’ skin. 30 per box - 15 sets of 2 (left & R
• 10812594013246 - NeoSnug Oral - Small: 2024-10-22 NeoSnug is intended to support, secure, and hold gastrointestinal tubes on patients’ skin. 40 pieces
• 00812594012082 - NeoLead®: 2023-11-07 NeoLead is a set of three/five ECG electrodes used on term neonates, infants, and pediatric patients. An electrocardiograph elec
• 00812594011467 - EZ Care Softouch Large - Black: 2023-09-18 Trach Holder 18" - Tan
• 10812594012928 - NeoSnug: 2023-09-18 Tubing Holder - Unique shape ideal for securing tubes close to the nares - 15 sets of 2 (Left/Right)
• 00812594013430 - NeoSmile Hydrogel: 2023-09-15 Hydrogel Temp Probe 75pcs / Box
• 00812594013478 - Neotech Bridge - Kit: 2023-06-14 Breastfeeding Assistance Device - Kit
• 00812594012600 - Neotech Bridge (30 pcs): 2023-06-14 Breastfeeding Assistance Device (30 pcs per Box)