FDA.reportPublic FDA data

NAJA

Primary DI
00191506060985
Brand
NAJA
Company
Médical Chess Inc
Model
9A-03110
Catalog number
9A-03110
Device description
Gastrointestinal Balloon Catheter
Published
2025-05-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FGDCATHETER, RETENTION, BARIUM ENEMA WITH BAG

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGDCatheter, Retention, Barium Enema With BagGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191506060985PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191506060985001915060609851915060609850191506060985

GMDN Terms#

Term, Definition table
TermDefinition
Enteroclysis balloon catheterA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
243279393
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30815112021499Tubing Clamp: Fits Standard 5/16' TubingBracco Diagnostics Inc.FGD2025-06-01
10815112021532Junior Flexi Tip Pediatric Enema TipBracco Diagnostics Inc.FGD2025-05-30
10815112021587Enema Kit: Empty Enema Bag Delivery SystemBracco Diagnostics Inc.FGD2025-05-30
10815112021631Miller Enema Air Tip: Without Retention CuffBracco Diagnostics Inc.FGD2025-05-30
1081511202164814 French Pediatric Flexi TipBracco Diagnostics Inc.FGD2025-05-30
10815112021655FLEXI-STOME Cone Colostomy TipBracco Diagnostics Inc.FGD2025-05-30
10815112021662Safti CuffBracco Diagnostics Inc.FGD2025-05-30
10815112021679Remote Blue Air Bulb Insufflator Air Insufflation of ColonBracco Diagnostics Inc.FGD2025-05-30
00815112021535Junior Flexi Tip Pediatric Enema TipBracco Diagnostics Inc.FGD2025-05-30
10815112021556SaftiCuff DKBracco Diagnostics Inc.FGD2025-05-30
10815112021563Super XL Enema SystemBracco Diagnostics Inc.FGD2025-05-30
30815112021581Enema Kit: Empty Enema Bag Delivery SystemBracco Diagnostics Inc.FGD2025-05-30
10815112021594EXACTA l Screw Cap Bag: Empty Enema Bag Delivery SystemBracco Diagnostics Inc.FGD2025-05-30
1081511202162424 Fr Infant Flexi Tip: Pediatric Enema TipBracco Diagnostics Inc.FGD2025-05-30
30815112021635Miller Enema Air Tip: Without Retention CuffBracco Diagnostics Inc.FGD2025-05-30
0081511202164114 French Pediatric Flexi TipBracco Diagnostics Inc.FGD2025-05-30
30815112021659FLEXI-STOME Cone Colostomy TipBracco Diagnostics Inc.FGD2025-05-30
30815112021666Safti CuffBracco Diagnostics Inc.FGD2025-05-30
30815112021673Remote Blue Air Bulb Insufflator Air Insufflation of ColonBracco Diagnostics Inc.FGD2025-05-30
10815112021525Enema Ring: Fluid Collection DeviceBracco Diagnostics Inc.FGD2025-05-16
30815112021529Enema Ring: Fluid Collection DeviceBracco Diagnostics Inc.FGD2025-05-16
10815112021167Rounded Flexi Tip Adult Enema TipBracco Diagnostics Inc.FGD2023-05-25
10815112021181Miller Enema Air Tip with Non-Latex Retention CuffBracco Diagnostics Inc.FGD2023-05-25
10815112021198Miller Enema Air Tip with Retention CuffBracco Diagnostics Inc.FGD2023-05-25
10815112021211Blue Air Bulb InsufflatorBracco Diagnostics Inc.FGD2023-05-25
10815112021228Retention Cuff InflatorBracco Diagnostics Inc.FGD2023-05-25
30815112021161Rounded Flexi Tip Adult Enema TipBRACCO DIAGNOSTICS INCFGD2023-05-25
10815112021174Enema Kit: Empty Enema Bag Delivery SystemBracco Diagnostics Inc.FGD2023-05-25
00815112021184Miller Enema Air Tip with Non-Latex Retention CuffBRACCO DIAGNOSTICS INCFGD2023-05-25
00815112021191Miller Enema Air Tip with Retention CuffBRACCO DIAGNOSTICS INCFGD2023-05-25