FDA.reportPublic FDA data

AMD-RITMED

Primary DI
20686864042956
Brand
AMD-RITMED
Company
AMD Medicom Inc
Model
53801
Catalog number
53801
Device description
AMD-RITMED GT DRAINAGE BAGS WITH SPOUT
Published
2019-01-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EYZSYSTEM, URINE DRAINAGE, CLOSED, FOR NONINDWELLING CATHETER, STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYZSystem, Urine Drainage, Closed, For Nonindwelling Catheter, SterileGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20686864042956PrimaryGS10
00686864042952Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2068686404295620686864042956
00686864042952006868640429526868640429520686864042952

GMDN Terms#

Term, Definition table
TermDefinition
Gastric drainage/decompression bagA plastic sac intended to be used to collect stomach contents during gastric drainage/decompression, via an enteral tube (not included), to drain/empty stomach contents (e.g., prior to surgery, as therapy for obstructed bowel). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Cool dry place

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(514)636-6262dabecassis@amdritmed.com
+1(514)636-6262amdudi@medicom.ca

Regulatory Flags#

DUNS number
256880576
Device count
50
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10686864061998Ocean Pacific NeoNatural1229-B1229-B2026-06-29
10686864062001Ocean Pacific NeoNatural1229-C1229-C2026-06-29
10686864062018Ocean Pacific NeoNatural1229-D1229-D2026-06-29
10686864062032Ocean Pacific NeoNatural1229B-SP61229B-SP62026-06-29
10686864062049Ocean Pacific NeoNatural1229C-SP61229C-SP62026-06-29
10686864062056Ocean Pacific NeoNatural1229D-SP61229D-SP62026-06-29
10686864016110Medicom AssureTouch9998-E9998-E2022-09-28
10686864029110Medicom AssureTouch9999-A9999-A2022-09-28
10686864048876AMD-RITMED SOLON55900559002023-07-10
10686864053955Medicom AssureTouch9950-C9950-C2022-09-28
10686864053962Medicom AssureTouch9950-D9950-D2022-09-28
10686864053979Medicom AssureTouch9950-E9950-E2022-09-28
10686864053986Medicom AssureTouch9950-F9950-F2022-09-28
10686864055058Medicom AssureTouch9950-B9950-B2022-09-28
10686864060113Medicom AssureTouch9985-A9985-A2023-07-27
10686864060120Medicom AssureTouch9985-B9985-B2023-07-27
10686864060137Medicom AssureTouch9985-C9985-C2023-07-27
10686864060144Medicom AssureTouch9985-D9985-D2023-07-27
10686864060151Medicom AssureTouch9985-E9985-E2023-07-27
20686864021661AMD-RITMED5100-B5100-B2019-01-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840118607346ENDURE INDUSTRIESENDURE INDUSTRIESEYZ2023-10-14
00840118611930ENDURE INDUSTRIESENDURE INDUSTRIESEYZ2023-10-14
00610075105618HollisterHOLLISTER INCORPORATEDEYZ2022-12-01
20610075093469HollisterHOLLISTER INCORPORATEDEYZ2022-12-01
20610075096453HollisterHOLLISTER INCORPORATEDEYZ2022-12-01
20610075096552HollisterHOLLISTER INCORPORATEDEYZ2022-12-01
20610075105612HollisterHOLLISTER INCORPORATEDEYZ2022-12-01
10080196028863MEDLINEMEDLINE INDUSTRIES, INC.EYZ2022-01-16
36641670005589SmartTap™ Paracentesis Drainage Bag, 4LCardiomed Supplies IncEYZ2020-11-27
36641670005626SmartTap™ Paracentesis Drainage Bag, 2LCardiomed Supplies IncEYZ2020-11-27
16641670005578SmartTap™ Paracentesis Drainage Bag, 4LCardiomed Supplies IncEYZ2020-11-27
16641670005615SmartTap™ Paracentesis Drainage Bag, 2LCardiomed Supplies IncEYZ2020-11-27
00810050241137N/ADOMICO MED-DEVICE, LLCEYZ2020-09-24
00810050242202N/ADOMICO MED-DEVICE, LLCEYZ2020-09-24
05055788767459EZ-Flow Catheter ValveFLEXICARE MEDICAL LIMITEDEYZ2020-03-25
20686864042963AMD-RITMEDAMD Medicom IncEYZ2019-01-24
10884521003446DoverCardinal Health, Inc.EYZ2018-06-27
10884521003453DoverCardinal Health, Inc.EYZ2018-06-27
20884521003443DoverCardinal Health, Inc.EYZ2018-06-27
20884521003450DoverCardinal Health, Inc.EYZ2018-06-27
10080196028856MedlineMEDLINE INDUSTRIES, INC.EYZ2016-10-14
10080196183012MedlineMEDLINE INDUSTRIES, INC.EYZ2016-10-14
10080196183401MedlineMEDLINE INDUSTRIES, INC.EYZ2016-10-14
10080196183418MedlineMEDLINE INDUSTRIES, INC.EYZ2016-10-14
10080196183531MedlineMEDLINE INDUSTRIES, INC.EYZ2016-10-14
40080196028857MedlineMEDLINE INDUSTRIES, INC.EYZ2016-10-14
40080196183013MedlineMEDLINE INDUSTRIES, INC.EYZ2016-10-14
40080196183402MedlineMEDLINE INDUSTRIES, INC.EYZ2016-10-14
10080196028825MedlineMEDLINE INDUSTRIES, INC.EYZ2016-09-29
10080196028894MedlineMEDLINE INDUSTRIES, INC.EYZ2016-09-29