AccessGUDID - DEVICE: Kangaroo (10192253007893)

GUDID

Device Identifier (DI) Information

Brand Name: Kangaroo
Version or Model: 461236E
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 461236E
Company Name: Cardinal Health 200, LLC

Primary DI Number: 10192253007893
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: Feeding Tube with IRIS Technology

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
16798	Nasoenteral tube	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNT	Tubes, gastrointestinal (and accessories)
PIF	Gastrointestinal Tubes with Enteral Specific Connectors

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a2bbaf99-2242-4077-a8a7-4887fbb6a356
Public Version Date: May 22, 2025
Public Version Number: 2
DI Record Publish Date: October 20, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
50192253007891	5	10192253007893		In Commercial Distribution	CASE

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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