FDA.reportPublic FDA data

Melker

Primary DI
00827002062467
Brand
Melker
Company
COOK INCORPORATED
Model
G06246
Catalog number
C-TCCS-400
Device description
Melker Uncuffed Emergency Cricothyrotomy Catheter Set
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
JOHTube tracheostomy and tube cuff

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOHTube Tracheostomy And Tube CuffAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00827002062467PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00827002062467008270020624678270020624670827002062467

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
10887709205281BivonaICU MEDICAL, INC.JOH2026-10-01
10887709205298BivonaICU MEDICAL, INC.JOH2026-10-01
10887709205304BivonaICU MEDICAL, INC.JOH2026-10-01
10887709205311BivonaICU MEDICAL, INC.JOH2026-10-01
10887709205328BivonaICU MEDICAL, INC.JOH2026-10-01
10887709205335BivonaICU MEDICAL, INC.JOH2026-10-01
10887709205342BivonaICU MEDICAL, INC.JOH2026-10-01
10887709205359BivonaICU MEDICAL, INC.JOH2026-10-01
10887709205366BivonaICU MEDICAL, INC.JOH2026-10-01
10887709205373BivonaICU MEDICAL, INC.JOH2026-10-01
10887709205380BivonaICU MEDICAL, INC.JOH2026-10-01
10887709205397BivonaICU MEDICAL, INC.JOH2026-10-01
10887709205410BivonaICU MEDICAL, INC.JOH2026-10-01
10887709205427BivonaICU MEDICAL, INC.JOH2026-10-01
10887709205014BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205021BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205038BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205045BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205052BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205069BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205076BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205083BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205199BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205205BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205212BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205229BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205236BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205243BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205250BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205267BivonaICU MEDICAL, INC.JOH2026-09-30