DEVICE: BD Intraosseous Vascular Access System (00801741163586)

Device Identifier (DI) Information

BD Intraosseous Vascular Access System
D015151NK
In Commercial Distribution
D015151NK
Bard Access Systems, Inc.
00801741163586
GS1

1
044611812 *Terms of Use
BD Intraosseous Needle Set Kit
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Device Characteristics

MR Unsafe
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?
18009 Intraosseous infusion kit
A collection of sterile devices designed to perform an intraosseous (IO) infusion (i.e., an infusion directly into the bone's medullary cavity for the purpose of administering emergency medications and other fluids). It typically consists of a needle (possibly of a special design), an inserting handle, a scalpel, an infusion set, swabs and sutures. This device is used as an alternate to the preferred intravenous (IV) route when this cannot be established in a timely manner, typically during cardiac arrest, patients with respiratory failure or in shock, and when peripheral IV infusion is very difficult. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FMI Needle, hypodermic, single lumen
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
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: 15 Millimeter
Needle Gauge: 15 Gauge
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Device Record Status

ce9fb6a7-01f1-419a-88c7-2ab2c61e68f8
December 03, 2019
1
November 25, 2019
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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
20801741163580 2 10801741163583 In Commercial Distribution BX
10801741163583 6 00801741163586 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)545-0890
medical.services@crbard.com
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