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 ID00812594010118
NIH Device Record Key86a49b60-8d5d-4dc8-b093-1213e14d3972
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeoBar NeoNatal Assorted
Version Model Number00812594011849
Catalog NumberN719N
Company DUNS198013435
Company NameNEOTECH PRODUCTS, INC.
Device Count12
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100812594010118 [Unit of Use]
GS100812594011832 [Primary]
GS100812594011849 [Primary]

FDA Product Code

CBHDevice, Fixation, Tracheal Tube

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-10
Device Publish Date2021-06-02

Devices Manufactured by NEOTECH PRODUCTS, INC.

00812594011405 - Little Sucker Cover2022-05-31 Protective Cover (Qty. 50)
10812594010795 - Meconium Aspirator2022-01-24
10812594010818 - Meconium Aspirator Tinted2022-01-24
10812594012584 - NeoBond Shapes (Hearts) (N7426)2022-01-24
00812594010330 - NeoBond2021-06-23 Hydrocolloid Strip
00812594011603 - NeoBond2021-06-23 Hydrocolloid Roll - 1" x 15' Roll
00812594012198 - EZCare Softouch - Pink2021-06-23 Trach Holder 6" - Pink
00812594012204 - EZCare Softouch - Pink2021-06-23 Trach Holder 7" - Pink

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