SureStep Male External Catheter System Blue Replacement Kit MECRB030

GUDID 10801741183666

SureStep Male External Catheter System Blue Replacement Kit

C. R. Bard, Inc.

Urinary incontinence penis sheath/port, single-use, non-sterile
Primary Device ID10801741183666
NIH Device Record Keyd7672b6d-7335-47dd-bf20-1c6c79d9aadf
Commercial Distribution StatusIn Commercial Distribution
Brand NameSureStep Male External Catheter System Blue Replacement Kit
Version Model NumberMECRB030
Catalog NumberMECRB030
Company DUNS016898496
Company NameC. R. Bard, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(800)526-4455
Emailmedical.services@crbard.com
Phone+1(800)526-4455
Emailmedical.services@crbard.com
Phone+1(800)526-4455
Emailmedical.services@crbard.com
Phone+1(800)526-4455
Emailmedical.services@crbard.com
Phone+1(800)526-4455
Emailmedical.services@crbard.com
Phone+1(800)526-4455
Emailmedical.services@crbard.com
Phone+1(800)526-4455
Emailmedical.services@crbard.com
Phone+1(800)526-4455
Emailmedical.services@crbard.com
Phone+1(800)526-4455
Emailmedical.services@crbard.com
Phone+1(800)526-4455
Emailmedical.services@crbard.com
Phone+1(800)526-4455
Emailmedical.services@crbard.com
Phone+1(800)526-4455
Emailmedical.services@crbard.com
Phone+1(800)526-4455
Emailmedical.services@crbard.com
Phone+1(800)526-4455
Emailmedical.services@crbard.com
Phone+1(800)526-4455
Emailmedical.services@crbard.com
Phone+1(800)526-4455
Emailmedical.services@crbard.com
Phone+1(800)526-4455
Emailmedical.services@crbard.com
Phone+1(800)526-4455
Emailmedical.services@crbard.com
Phone+1(800)526-4455
Emailmedical.services@crbard.com
Phone+1(800)526-4455
Emailmedical.services@crbard.com
Phone+1(800)526-4455
Emailmedical.services@crbard.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100801741183669 [Primary]
GS110801741183666 [Package]
Contains: 00801741183669
Package: CA [1 Units]
In Commercial Distribution

FDA Product Code

PPCMale external catheterization kit (excludes HIV testing)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-30
Device Publish Date2020-09-22

Devices Manufactured by C. R. Bard, Inc.

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10801741226981 - PureWick2024-08-06 PureWick Flex Female External Catheter, Home Care
10801741226462 - PureWick2024-06-10 PureWick Male External Catheter, Home Care
10801741226950 - PureWick2024-06-10 PureWick Flex Female External Catheter Kit
10801741218788 - SureStep Foley Tray System2024-05-21 SureStep Foley Tray Kit optimized for Sensica UO System
10801741218832 - SureStep Foley Tray System2024-05-21 SureStep Foley Tray Kit optimized for Sensica UO System
10801741171663 - Bardia2023-08-29 Bardia Silicone Elastomer Coated Foley Catheter
20801741171677 - Bardia2023-08-29 Bardia Silicone Elastomer Coated Foley Catheter

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