FDA.reportPublic FDA data

SaftiCuff DK

Primary DI
10815112020900
Brand
SaftiCuff DK
Company
Bracco Diagnostics Inc.
Model
900910
Catalog number
900910
Device description
Safticuff DL Airway
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
30815112020904PackageGS175In Commercial Distribution
10815112020900PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3081511202090430815112020904
1081511202090010815112020900

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 Gauge48French

Contacts#

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

Regulatory Flags#

DUNS number
849234661
Device count
1
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