DEVICE: Ster-ASSIST ™ (04046964712593)

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Device Identifier (DI) Information

Ster-ASSIST ™
375500
375500
B. BRAUN MEDICAL INC.
04046964712593
GS1
10
Introcan Safety® 20 Ga. x 1.75 in., Straight, FEP and CARESITE® Smallbore Extension Set with bonded CARESITE Luer Access Device, Spin-Lock<sup>® connector and removable slide clamp, 8 in. (20cm). For use with power injector
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Device Characteristics

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

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Peripheral vascular catheter A sterile, thin, flexible tube intended to be inserted into the peripheral vasculature of a patient to enable short-term (< 30 days) intravascular access; it is not intended to be advanced to the central vasculature. It typically includes dedicated accessories to facilitate catheter introduction/placement and function (e.g., connectors, injection ports, stylet and/or wings for fixation). It may be used for blood sampling, monitoring of blood pressure, to administer fluids, medication and/or for the injection of contrast media. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
OWL Peripheral catheter insertion kit
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Sterilization

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

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Storage and Handling
Storage Environment Temperature: between 20 and 25 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Gauge (cannula) : 20
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Device Status

In Commercial Distribution
September 23, 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

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

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Unit of Use DI Number: 04046964712586 CLOSE

Direct Marking (DM)

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

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)227-2862
BBMUS_Service.EmailOrders@bbraun.com
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