FDA.reportPublic FDA data

Cook

Primary DI
10827002223001
Brand
Cook
Company
COOK INCORPORATED
Model
G22300
Catalog number
NJFT-8
Device description
Nasal Jejunal Feeding Tube
Published
2016-09-24
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
KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K043203000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043203000WILSON-COOK ENTERAL FEEDING TUBE, TIGER TUBE ENTERAL FEEDING TUBEWilson-Cook Medical, Inc.2005-05-11KNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10827002223001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1082700222300110827002223001

GMDN Terms#

Term, Definition table
TermDefinition
Nasoenteral tubeA sterile, thin, flexible, hollow cylinder designed to access the small intestines (duodenum or jejunum) through the nose and nasopharynx for examination (e.g., of intestinal contents), treatment (e.g., decompression, short-term feeding), or other purposes. It is a single- or dual-lumen, rubber or plastic tube (nasoduodenal or nasojejunal tube) that is smaller and longer than a nasogastric tube and may have a small weight or magnet at the distal tip to facilitate placement. It is frequently used for very ill or comatose patients. Some types are used to remove air and liquids from the stomach by connection to intermittent suction units and/or for enteral feeding. This is a single-use device.

Storage And Handling#

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

Contacts#

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

Regulatory Flags#

DUNS number
079720472
Device count
1
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00350770997841MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997858MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997896MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997902MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997919MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997964MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997971MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
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