FDA.reportPublic FDA data

Retention Cuff Inflator

Primary DI
00815112021221
Brand
Retention Cuff Inflator
Company
BRACCO DIAGNOSTICS INC
Model
900405
Catalog number
900405
Device description
One Shot Cuff Inflator
Published
2023-05-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

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
30815112021222PackageGS112In Commercial Distribution
10815112021228PrimaryGS10
00815112021221Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3081511202122230815112021222
1081511202122810815112021228
00815112021221008151120212218151120212210815112021221

GMDN Terms#

Term, Definition table
TermDefinition
Barium enema catheterA flexible tube designed to administer barium, a contrast medium, into the lower gastrointestinal tract by way of the rectum, for radiographic visualization of the area. The rubber or plastic tube may also be used for colonoscopy and can have a silicone rubber retention balloon tip for the examination of incontinent persons. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
609-514-2200xx@xx.xx

Regulatory Flags#

DUNS number
849234661
Device count
12
DM exempt
false
Premarket exempt
true
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30815112021390CardioGen-82 Infusion System Model 17000017002023-12-01
30815112021352CardioGen Patient Administration Set0015062023-10-16
30815112021369Vented Cap for Waste Bottle 0015112023-10-16
30815112021376Waste Bottle0015202023-10-16
30815112021239Protocol Touch Colon Insufflator3903083903082023-08-31
30815112021086Enteroclysis Admin Kit9014039014032016-09-19
30815112021260Protocol Accessory Cart3903053903052023-07-07
30815112021246Protocol Touch Administration Set with Small Catheter and Retention Cuff3903093903092023-06-29
30815112021284Protocol Administration Set with Small Catheter and Retention Cuff3904023904022023-06-29
50815112021332Accessory Package0017102023-06-29
30815112021161Rounded Flexi Tip Adult Enema Tip9013019013012023-05-25
00815112021184Miller Enema Air Tip with Non-Latex Retention Cuff9012019012012023-05-25
00815112021191Miller Enema Air Tip with Retention Cuff9012029012022023-05-25
00815112021214Blue Air Bulb Insufflator9004049004042023-05-25
30815112020041Vented Cap for Waste Bottle 0015112023-03-22
30815112020058Waste Bottle0015202023-03-22
50815112020038Accessory Package0015102023-03-22
50815112020618Accessory Package0017102023-03-22
30815112020539E-Z-GEL UltraSound Gel6010016010012016-09-23
30815112020546E-Z-SCAN Low Viscosity UltraSound Gel6010026010022016-09-23

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
00191506060985NAJAMédical Chess IncFGD2025-05-23
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