FDA.reportPublic FDA data

18 French Pediatric Flexi Tip

Primary DI
10815112021068
Brand
18 French Pediatric Flexi Tip
Company
Bracco Diagnostics Inc.
Model
901308
Catalog number
901308
Device description
18 Fr Pediatric Flexi Tip
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
30815112021062PackageGS124In Commercial Distribution
10815112021068PrimaryGS10
00815112021061Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3081511202106230815112021062
1081511202106810815112021068
00815112021061008151120210618151120210610815112021061

GMDN Terms#

Term, Definition table
TermDefinition
Enema tip, single-useA device intended to be connected to an enema tube to facilitate delivery of an enema solution into the rectum; it is not intended to be used during colonic irrigation. It is typically designed as a one-piece, synthetic polymer, moulded nozzle that may have a slight bulb shape at the distal end to improve retention in the rectum. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge18French

Contacts#

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

Regulatory Flags#

DUNS number
849234661
Device count
12
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10815112020214Fast Find Grid: Disposable CT Biopsy Grid6000016000012016-09-19
10815112021167Rounded Flexi Tip Adult Enema Tip9013019013012023-05-25
10815112021181Miller Enema Air Tip with Non-Latex Retention Cuff9012019012012023-05-25
10815112021198Miller Enema Air Tip with Retention Cuff9012029012022023-05-25
30815112021703Two Tank Shuttle Valve System7106027106022025-06-30
30815112021710DIN 477 High Pressure Hose for CO23905133905132025-06-30
30815112021291High Pressure Hose and Yoke7106037106032023-08-31
10815112021174Enema Kit: Empty Enema Bag Delivery System9003029003022023-05-25
1081511202120418 French Pediatric Flexi Tip9013089013082023-05-25
30815112020805High Pressure DISS Hose For CO27106047106042016-09-19
30815112020782Two Tank Shuttle Valve System7106027106022016-09-19
10815112020535E-Z-GEL UltraSound Gel6010016010012016-09-23
10815112020542E-Z-SCAN Low Viscosity UltraSound Gel6010026010022016-09-23
10815112020559E-Z-SCAN Low Viscosity UltraSound Gel6010036010032016-09-23
10815112020566E-Z-GEL UltraSound Gel6010046010042016-09-23
10815112021402E-Z-GEL UltraSound Gel6010016010012025-05-16
10815112021419E-Z-SCAN Low Viscosity UltraSound Gel6010026010022025-05-16
10815112021426E-Z-SCAN Low Viscosity UltraSound Gel6010036010032025-05-16
10815112021433E-Z-GEL UltraSound Gel6010046010042025-05-16
10815112020856"""Y"" Connector with Tubing"9004029004022016-09-19

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