ACU 1060.1 Transtracheal Catheter ACU 1060.1

GUDID M996ACU106010

ACU 1060.1 Transtracheal Catheter provides tracheal access for manual jet ventilators. The attached syringe helps to determine correct needle placement in the trachea by air aspiration. Needle size: 13Gauge / Adult RX only.

INSTRUMENTATION INDUSTRIES, INCORPORATED

Oxygen administration transtracheal catheter Oxygen administration transtracheal catheter Oxygen administration transtracheal catheter Oxygen administration transtracheal catheter Oxygen administration transtracheal catheter Oxygen administration transtracheal catheter Oxygen administration transtracheal catheter Oxygen administration transtracheal catheter Oxygen administration transtracheal catheter Oxygen administration transtracheal catheter Oxygen administration transtracheal catheter Oxygen administration transtracheal catheter Oxygen administration transtracheal catheter Oxygen administration transtracheal catheter Oxygen administration transtracheal catheter Oxygen administration transtracheal catheter
Primary Device IDM996ACU106010
NIH Device Record Key8aeac706-4a19-47b6-97c7-339f9aeba519
Commercial Distribution StatusIn Commercial Distribution
Brand NameACU 1060.1 Transtracheal Catheter
Version Model NumberACU 1060.1
Catalog NumberACU 1060.1
Company DUNS053146767
Company NameINSTRUMENTATION INDUSTRIES, INCORPORATED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone4128541133
Emailraqa@iiimedical.com
Phone4128541133
Emailraqa@iiimedical.com
Phone4128541133
Emailraqa@iiimedical.com
Phone4128541133
Emailraqa@iiimedical.com
Phone4128541133
Emailraqa@iiimedical.com
Phone4128541133
Emailraqa@iiimedical.com
Phone4128541133
Emailraqa@iiimedical.com
Phone4128541133
Emailraqa@iiimedical.com
Phone4128541133
Emailraqa@iiimedical.com
Phone4128541133
Emailraqa@iiimedical.com
Phone4128541133
Emailraqa@iiimedical.com
Phone4128541133
Emailraqa@iiimedical.com
Phone4128541133
Emailraqa@iiimedical.com
Phone4128541133
Emailraqa@iiimedical.com
Phone4128541133
Emailraqa@iiimedical.com
Phone4128541133
Emailraqa@iiimedical.com

Device Dimensions

Needle Gauge13 Gauge
Needle Gauge13 Gauge
Needle Gauge13 Gauge
Needle Gauge13 Gauge
Needle Gauge13 Gauge
Needle Gauge13 Gauge
Needle Gauge13 Gauge
Needle Gauge13 Gauge
Needle Gauge13 Gauge
Needle Gauge13 Gauge
Needle Gauge13 Gauge
Needle Gauge13 Gauge
Needle Gauge13 Gauge
Needle Gauge13 Gauge
Needle Gauge13 Gauge
Needle Gauge13 Gauge

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM996ACU106010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTOTube, Tracheostomy (W/Wo Connector)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-21
Device Publish Date2021-01-13

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