NeoBar NeoNatal Assorted N719N

GUDID 00812594010118

ET Tube Holder (12) 00812594010118 Endotracheal Tube Holder Qty. 2 00812594010064 Endotracheal Tube Holder Qty. 2 00812594010040 Endotracheal Tube Holder Qty. 2 00812594010071 Endotracheal Tube Holder Qty. 2 00812594011115 Endotracheal Tube Holder Qty. 2 00812594010057 Endotracheal Tube Holder Qty. 2

NEOTECH PRODUCTS, INC.

Wearable percutaneous catheter/tube holder

• Primary Device ID: 00812594010118
• NIH Device Record Key: 86a49b60-8d5d-4dc8-b093-1213e14d3972
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeoBar NeoNatal Assorted
• Version Model Number: 00812594011849
• Catalog Number: N719N
• Company DUNS: 198013435
• Company Name: NEOTECH PRODUCTS, INC.
• Device Count: 12
• 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	00812594010118 [Unit of Use]
GS1	00812594011832 [Primary]
GS1	00812594011849 [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: 2021-06-10
• Device Publish Date: 2021-06-02

Devices Manufactured by NEOTECH PRODUCTS, INC.

• 00812594011405 - Little Sucker Cover: 2022-05-31 Protective Cover (Qty. 50)
• 10812594010795 - Meconium Aspirator: 2022-01-24
• 10812594010818 - Meconium Aspirator Tinted: 2022-01-24
• 10812594012584 - NeoBond Shapes (Hearts) (N7426): 2022-01-24
• 00812594010330 - NeoBond: 2021-06-23 Hydrocolloid Strip
• 00812594011603 - NeoBond: 2021-06-23 Hydrocolloid Roll - 1" x 15' Roll
• 00812594012198 - EZCare Softouch - Pink: 2021-06-23 Trach Holder 6" - Pink
• 00812594012204 - EZCare Softouch - Pink: 2021-06-23 Trach Holder 7" - Pink