DEVICE: Bardia (00801741171727)
Device Identifier (DI) Information
Bardia
123524CE
In Commercial Distribution
123524CE
C. R. Bard, Inc.
123524CE
In Commercial Distribution
123524CE
C. R. Bard, Inc.
Bardia Silicone Elastomer Coated Foley Catheter
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
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No | |
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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? |
---|---|---|---|---|
34917 | Indwelling urethral drainage balloon catheter, non-antimicrobial |
A flexible tube with an inflatable balloon at its distal tip intended to be inserted through the urethra and retained in the urinary bladder, or prostatic bed, of an adult or paediatric patient to function as an indwelling therapeutic device for urinary drainage; it might also be designed for infusion of fluids (irrigation). It may have a bent tip (coude) to facilitate insertion, and some types may be provided with a guidewire to facilitate difficult insertion (e.g., in cases of enlarged prostate); it does not include an antimicrobial agent(s). Most types are commonly known as a Foley catheter; it is intended to be introduced by a healthcare professional. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EZC | CATHETER, COUDE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Store catheters at room temperature away from direct exposure to light, preferably in the original box. |
Clinically Relevant Size
[?]Size Type Text |
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Catheter Gauge: 24 French |
Total Volume: 5 Milliliter |
Device Record Status
4144c14f-efb3-4317-9dda-0386ace9f87b
August 29, 2023
1
August 21, 2023
August 29, 2023
1
August 21, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10801741171724 | 10 | 00801741171727 | In Commercial Distribution | BX | |
20801741171721 | 32 | 00801741171727 | In Commercial Distribution | CA |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)526-4455
medical.services@crbard.com
medical.services@crbard.com