DEVICE: Elite HV® (04046964348662)

Device Identifier (DI) Information

Elite HV®
612908
In Commercial Distribution
612908
B BRAUN INTERVENTIONAL SYSTEMS, INC
04046964348662
GS1

10
784259751 *Terms of Use
6FR X 12CM X .038 HEMO PT INTRODUCER SET
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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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
58865 Vascular catheter introduction set, nonimplantable
A collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DYB INTRODUCER, CATHETER
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K043525 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify:
Special Storage Condition, Specify: Store at room temp
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Clinically Relevant Size

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

156af9d4-3a24-4fd2-9d12-e38e8baed845
September 07, 2023
6
August 09, 2016
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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
No Package DIs found
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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: 04046964348648 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(877)836-2228
GUDID.BBMUS_Service@bbraun.com
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