FDA.report

Codan

Primary DI
00813153024980
Brand
Codan
Company
Codan US Corporation
Model
EF 114
Device description
Mixing Cannula 4 inch
Published
2018-05-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
KNTTubes, Gastrointestinal (And Accessories)

Product Code Classifications

CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00813153024980PackageGS11In Commercial Distribution
10813153024987PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00813153024980008131530249808131530249800813153024980
1081315302498710813153024987

GMDN Terms

TermDefinition
Enteral feeding kit, infantA collection of sterile devices that includes tubing and other materials intended to administer nutrient liquids directly into the stomach, duodenum, or jejunum of an infant patient by means of gravity or an enteral pump. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
058027475
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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00813153027899CodanBC5312026-02-25
00813153028124FRESENIUS KABIFK20209KE2026-02-05
00813153028131FRESENIUS KABIFK20253KE2026-02-05
00813153028148FRESENIUS KABIFK20257KE2026-02-05
00813153028155FRESENIUS KABIFK20258KE2026-02-05
00813153028179CodanBC22262026-01-21
00813153027882LABEL PRODUCT -CODANBC5332025-08-27
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00813153028001Kabi Access Infusion SetsFK70110K2025-08-27
00813153028018Kabi Access Infusion SetsFK70111K2025-08-27
00813153028025LABEL PRODUCT -CODANC3092025-08-27
00813153027929LABEL PRODUCT -CODANB6852025-08-27
00813153027875LABEL PRODUCT -CODANBC5322025-08-26
00813153027912LABEL PRODUCT -CODANBC1582025-08-26
00813153027943LABEL PRODUCT -CODANBC2191N2025-08-26
00813153027950LABEL PRODUCT -CODANBC2192N2025-08-26
00813153028049LABEL PRODUCT -CODANBC2193N2025-08-26
00813153028087LABEL PRODUCT -CODANA4872025-08-26

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