FDA.reportPublic FDA data

Enteroclysis Catheter 13Fx155cm

Primary DI
50815112021097
Brand
Enteroclysis Catheter 13Fx155cm
Company
BRACCO DIAGNOSTICS INC
Model
901501
Catalog number
901501
Device description
Enteroclysis Cath 13F w/Ball
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EZKCatheter, Retention Type

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZKCatheter, Retention TypeGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K911349000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K911349000E-Z-EM ENTEROCLYSIS CATHETER SETE-Z-Em, Inc.1992-11-16EZK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50815112021097PackageGS124In Commercial Distribution
30815112021093PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5081511202109750815112021097
3081511202109330815112021093

GMDN Terms#

Term, Definition table
TermDefinition
Barium enema kitA packaged collection of items used to deliver a suspension of barium into the colon via the rectum to function as a contrast agent for radiological examination of the bowel. 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
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
00815112021221Retention Cuff Inflator9004059004052023-05-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10815112021082Enteroclysis Admin KitBracco Diagnostics Inc.EZK2016-09-19
30815112021093Enteroclysis Catheter 13Fx155cmBracco Diagnostics Inc.EZK2016-09-19
30815112021086Enteroclysis Admin KitBRACCO DIAGNOSTICS INCEZK2016-09-19