FDA.reportPublic FDA data

Arndt

Primary DI
00827002576254
Brand
Arndt
Company
COOK INCORPORATED
Model
G57625
Catalog number
C-CAE-14.0-70-LMA-01
Device description
Arndt Airway Exchange Catheter Set with Rapi-Fit Adapters
Published
2020-03-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTRTube, tracheal (w/wo connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTRTube, Tracheal (W/Wo Connector)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162729000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162729000Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft TipCook Incorporated2017-08-11BSR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002576254PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002576254008270025762548270025762540827002576254

GMDN Terms#

Term, Definition table
TermDefinition
Endotracheal tube guide, single-useA device used to provide guidance when it is necessary to exchange an endotracheal (ET) tube which has been intubated into a patient. The guide is inserted into the existing tube which is then retracted over the guide. The new ET tube is inserted over the guide to facilitate its correct passage, and the guide is removed once the new tube is satisfactorily in place. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place. Avoid extended exposure to light.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(812)330-5494sharedservices@cookmedical.com

Regulatory Flags#

DUNS number
042823948
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00827002007475CookG00747T9.0-65-45-M-NS-TJC2016-09-24
00827002071261CookG07126T9.0-65-45-NM-NS-TJC2016-09-24
00827002342538AprimaG34253NSSW-4.0-18-NPAS-100-HC-SST2020-10-15
00827002067622CookG06762PLVW-5.5-25-PICS2020-10-02
00827002116306ChaitG11630CTU10.0-18-CAA2020-10-02
00827002577862Check-Flo PerformerG57786RCF-4.0-21-7-J-012020-07-07
00827002577879Check-Flo PerformerG57787RCF-4.0-35-J-012020-07-07
00827002577886Check-Flo PerformerG57788RCF-5.0-35-J-012020-07-07
00827002577893Check-Flo PerformerG57789RCF-5.0-38-J-012020-07-07
00827002577909Check-Flo PerformerG57790RCF-6.0-35-J-012020-07-07
00827002577916Check-Flo PerformerG57791RCF-6.0-38-J-012020-07-07
00827002577923Check-Flo PerformerG57792RCF-7.0-35-J-012020-07-07
00827002577930Check-Flo PerformerG57793RCF-7.0-38-J-012020-07-07
00827002577947Check-Flo PerformerG57794RCF-8.0-38-J-012020-07-07
00827002577954Check-Flo PerformerG57795RCFP-5.5-25-J-012020-07-07
00827002577961Check-Flo PerformerG57796RCFW-5.0-35-012020-07-07
00827002275010TurcotteG27501HDC-500-TURCOTTE-0429922016-09-24
00827002275027TurcotteG27502HDC-600-TURCOTTE-0429922016-09-24
00827002313941VertefixG31394VBC-1002016-04-28
00827002363922ChaitG36392TDCS-100-M2016-09-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10884521853867ShileyCovidien LPBTR2026-10-25
10884521853874ShileyCovidien LPBTR2026-10-25
14026704934758LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDBTR2026-08-03
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14026704759580SHERIDANTELEFLEX INCORPORATEDBTR2026-07-29
00810003750822KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750839KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08