DEVICE: Bard Button Device Bolus Feeding Tube with Straight Adaptor (00801741080852)

Device Identifier (DI) Information

Bard Button Device Bolus Feeding Tube with Straight Adaptor
000259
Not in Commercial Distribution
000259
Bard Access Systems, Inc.
00801741080852
GS1
January 26, 2023
1
044611812 *Terms of Use
Bolus Tube for 24 Fr
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
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?
35419 Gastrostomy tube
A thin, flexible, percutaneous, hollow tube which may include additional external components (e.g., external tubing, syringe) intended to be percutaneously inserted into the stomach to feed a patient with a physical disability that prevents oral feeding (e.g., a birth defect of the stomach), and/or provide drainage/decompression of the stomach when it is necessary to bypass an obstruction of the stomach outlet into the small intestine. Although noninvasive disposable enteral feeding components may be included, surgical instruments and pharmaceutical agents are not included. This is a single-use device.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
KGC TUBE, GASTRO-ENTEROSTOMY
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No 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
Length: 25.4 Centimeter
Catheter Gauge: 24 French
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Device Record Status

06da82d3-b545-4ea1-b170-38d5f5fa2ce3
May 16, 2024
5
September 24, 2015
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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
10801741080859 17 00801741080852 2014-08-31 Not in Commercial Distribution BX
20801741080856 12 00801741080852 2023-01-26 Not in Commercial Distribution CA
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Secondary DI

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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)545-0890
medical.services@crbard.com
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