FDA.reportPublic FDA data

Cook

Primary DI
00827002094130
Brand
Cook
Company
COOK INCORPORATED
Model
G09413
Catalog number
C-DTJV-6.0-7.5-BTT
Device description
Emergency Transtracheal Airway Catheter
Published
2015-10-24
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
BWCNeedle, emergency airway

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BWCNeedle, Emergency AirwayAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002094130PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002094130008270020941308270020941300827002094130

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen administration transtracheal catheterA flexible tube intended to be introduced across the tracheal wall to provide supplementary oxygen (O2) to the respiratory tract of a person who is unable to breathe through the nose or mouth because of obstruction. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in dark, dry, cool place.

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
00827002011939KopansG01193DKBL-20-15.02020-10-02
00827002012585KopansG01258DKBL-21-15.02020-10-02
00827002025547KopansG02554DKBL-21-9.0-A2020-10-02
00827002025868KopansG02586DKBL-20-5.0-A2020-10-02
00827002025875KopansG02587DKBL-20-9.0-A2020-10-02
00827002026018KopansG02601DKBL-20-7.0-A2020-10-02
00827002028500KopansG02850DKBL-20-15.0-A2020-10-02
00827002029002KopansG02900DKBL-21-5.0-A2020-10-02
00827002029385KopansG02938DKBL-21-15.0-A2020-10-02
00827002035072KopansG03507DKBL-21-7.0-A2020-10-02
00827002037953KopansG03795DKBL-20-11.0-A2020-10-02
00827002042933KopansG04293DKBL-20-15.0-U2020-10-02
00827002042964KopansG04296DKBL-20-9.0-A-U2020-10-02
00827002043435KopansG04343DKBL-20-5.0-A-U2020-10-02
00827002053465KopansG05346DKBL-21-11.0-A2020-10-02
00827002058620KopansG05862DKBL-21-5.0-A-U2020-10-02
00827002073708KopansG07370DKBL-21-9.0-A-U2020-10-02
00827002090422KopansG09042DKBL-21-7.0-A-U2020-10-02
00827002099845KopansG09984DKBL-20-7.0-A-U2020-10-02
00827002099852KopansG09985DKBL-20-15.0-A-U2020-10-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250105630770ScalpelCricVBM Medizintechnik GmbHBWC2026-05-08
04250105629736ScalpelCricVBM Medizintechnik GmbHBWC2022-12-21
04250105628111n.a.VBM Medizintechnik GmbHBWC2020-11-09
14250105628118n.a.VBM Medizintechnik GmbHBWC2020-11-09
15019315110528PortexICU MEDICAL, INC.BWC2017-05-29
35019315110522PortexICU MEDICAL, INC.BWC2017-05-29
00827002077966PatilCOOK INCORPORATEDBWC2015-10-24
00827002082519ArndtCOOK INCORPORATEDBWC2015-10-24
00827002089501PatilCOOK INCORPORATEDBWC2015-10-24
00827002103382CookCOOK INCORPORATEDBWC2015-10-24
04026704111671RUSCHTELEFLEX INCORPORATEDBWC2015-10-16
15019315010989PortexICU MEDICAL, INC.BWC2015-09-01