FDA.reportPublic FDA data

Entuit

Primary DI
10827002472843
Brand
Entuit
Company
COOK INCORPORATED
Model
G47284
Catalog number
C-ENTUIT-14-S-ENF
Device description
Entuit Gastrostomy Set with ENFit Connection
Published
2020-08-21
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
PRRFeeding tube kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PRRFeeding Tube KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10827002472843PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1082700247284310827002472843

GMDN Terms#

Term, Definition table
TermDefinition
Gastrostomy tube kit, non-medicatedA collection of devices which includes a gastrostomy tube with additional surgical devices intended to create short- and/or long-term (= 24 hours) access to the stomach via a gastrostomy. In addition to the gastrostomy tube, the kit includes surgical cutting devices (e.g., scalpel) intended to perform the gastrostomy, and devices intended for tube introduction/function (e.g., introduction needle, guidewire, dilator, fastener, lubricant); it does not include any pharmaceutical agents. 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
Premarket exempt
true
Kit
true
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
10198956222090CARDINAL HEALTHCardinal Health 200, LLCPRR2025-11-02
10197106583913CARDINAL HEALTHCardinal Health 200, LLCPRR2024-04-16
50197106583911CARDINAL HEALTHCardinal Health 200, LLCPRR2024-04-16
10827002472850EntuitCOOK INCORPORATEDPRR2020-08-21
10827002472867EntuitCOOK INCORPORATEDPRR2020-08-21
10827002472874EntuitCOOK INCORPORATEDPRR2020-08-21
10827002472881EntuitCOOK INCORPORATEDPRR2020-08-21
10827002472898EntuitCOOK INCORPORATEDPRR2020-08-21
10827002472904EntuitCOOK INCORPORATEDPRR2020-08-21
10827002472911EntuitCOOK INCORPORATEDPRR2020-08-21
10193489782646MEDLINEMEDLINE INDUSTRIES, INC.PRR2020-05-18
20193489782643MEDLINEMEDLINE INDUSTRIES, INC.PRR2020-05-18
10193489191776MEDLINEMEDLINE INDUSTRIES, INC.PRR2020-04-15
20193489191773MEDLINEMEDLINE INDUSTRIES, INC.PRR2020-04-15
00653160056952CenturionCENTURION MEDICAL PRODUCTS CORPORATIONPRR2016-09-13
50653160056957CenturionCENTURION MEDICAL PRODUCTS CORPORATIONPRR2016-09-13