AccessGUDID - DEVICE: NAJA (00191506060985)

GUDID

Device Identifier (DI) Information

Brand Name: NAJA
Version or Model: 9A-03110
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9A-03110
Company Name: Médical Chess Inc

Primary DI Number: 00191506060985
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 243279393 *Terms of Use

Device Description: Gastrointestinal Balloon Catheter

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?
67509	Enteroclysis balloon catheter	A long, thin, flexible tube with one or more inflatable balloons at its distal tip designed to be introduced through the working channel of a gastroscope to access the small intestines (duodenum or jejunum) to administer fluids used for enteroclysis procedures (e.g., contrast medium), for radiographic visualization of the area. The balloon is inflated to its prescribed diameter to temporarily occlude the lumen of the small intestine to facilitate fluid infusion. It features a multichannel port at the proximal end for guidewire insertion, fluid infusion and individual balloon inflation. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FGD	CATHETER, RETENTION, BARIUM ENEMA WITH BAG

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a160d5bc-103f-4b4e-83e7-90ff33fa6cdd
Public Version Date: June 02, 2025
Public Version Number: 1
DI Record Publish Date: May 23, 2025

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

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

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES