FDA.reportPublic FDA data

Medline

Primary DI
40080196035732
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
DYND70110
Catalog number
DYND70110
Device description
TUBE,RECTAL,POLY-CATH,18FR,NON-STER,
Published
2021-01-05
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
40080196035732PackageGS110In Commercial Distribution
10080196035731PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4008019603573240080196035732
1008019603573110080196035731

GMDN Terms#

Term, Definition table
TermDefinition
Gravity enema setA collection of devices intended to be used to deliver an injection of fluid (e.g., saline solution) into the rectum to facilitate evacuation of the large intestine. It includes a fluid reservoir (e.g., enema bag) which acts as a gravity-flow chamber, and typically includes enema tube(s) and enema tip; it may be prefilled with a non-medicated enema solution and may be available preassembled. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge18French

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
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
false
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
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

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
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
30815112021529Enema Ring: Fluid Collection DeviceBracco Diagnostics Inc.FGD2025-05-16
30815112021161Rounded Flexi Tip Adult Enema TipBRACCO DIAGNOSTICS INCFGD2023-05-25
10815112021174Enema Kit: Empty Enema Bag Delivery SystemBRACCO DIAGNOSTICS INCFGD2023-05-25
00815112021184Miller Enema Air Tip with Non-Latex Retention CuffBRACCO DIAGNOSTICS INCFGD2023-05-25
00815112021191Miller Enema Air Tip with Retention CuffBRACCO DIAGNOSTICS INCFGD2023-05-25
1081511202120418 French Pediatric Flexi TipBRACCO DIAGNOSTICS INCFGD2023-05-25
00815112021214Blue Air Bulb InsufflatorBRACCO DIAGNOSTICS INCFGD2023-05-25
00815112021221Retention Cuff InflatorBRACCO DIAGNOSTICS INCFGD2023-05-25
40080196035749MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.FGD2021-01-05
10815112020634Enema Kit: Empty Enema Bag Delivery SystemBRACCO DIAGNOSTICS INCFGD2020-06-29
30815112020645FLEXI-STOME Cone Colostomy TipBRACCO DIAGNOSTICS INCFGD2020-06-29
30815112020812Enema Kit: Empty Enema Bag Delivery SystemBRACCO DIAGNOSTICS INCFGD2016-09-19
30815112020829Enema Kit: Empty Enema Bag Delivery SystemBRACCO DIAGNOSTICS INCFGD2016-09-19
10815112020832EXACTA l Screw Cap Bag: Empty Enema Bag Delivery SystemBRACCO DIAGNOSTICS INCFGD2016-09-19
10815112020870Blue Air Bulb InsufflatorBRACCO DIAGNOSTICS INCFGD2016-09-19
30815112020881Retention Cuff InflatorBRACCO DIAGNOSTICS INCFGD2016-09-19
30815112020959Enema Ring: Fluid Collection DeviceBRACCO DIAGNOSTICS INCFGD2016-09-19