DEVICE: SureStep Male External Catheter System Blue Replacement Kit (00801741183669)

Device Identifier (DI) Information

SureStep Male External Catheter System Blue Replacement Kit
MECRB030
In Commercial Distribution
MECRB030
C. R. Bard, Inc.
00801741183669
GS1

1
016898496 *Terms of Use
SureStep Male External Catheter System Blue Replacement Kit
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
No
Yes
Yes
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
34929 Urinary incontinence penis sheath/port, single-use
A device intended to be worn on or over the penis by an incontinent patient to channel urine from the penis, via a tube, into a collection bag. It consists of a penis-worn sheath (e.g., condom-catheter) or adhesive port (e.g., glans penis attachment), and may include a portion of tubing; the bag is not included. This device provides an alternative to inserting a catheter through the urethra, especially when difficulty is encountered in insertion or retention. It may be used to treat urinary incontinence or for non-ambulatory patients. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NNX DEVICE, INCONTINENCE, UROSHEATH TYPE, NON-STERILE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

d7672b6d-7335-47dd-bf20-1c6c79d9aadf
February 03, 2025
3
September 22, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10801741183666 1 00801741183669 In Commercial Distribution CA
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)526-4455
medical.services@crbard.com
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