DEVICE: Prager Ext Set B1263 (B360011B12630)

Device Identifier (DI) Information

Prager Ext Set B1263
011B1263
In Commercial Distribution
011B1263
ESI CORPORATION
B360011B12630
HIBCC

1
829391734 *Terms of Use
Replacement Part
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Basic intravenous administration set A collection of sterile devices designed to conduct fluids from an intravenous (IV) fluid container to a patient's venous system. It typically includes tubing, connectors, chambers, clamps, and needles or injection ports. It is typically used for gravitational intravenous administration. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
FMG Stopcock, I.V. Set
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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

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Size Type Text
Length: 14 Inch
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Device Record Status

d824b709-1cd3-4d50-9299-d37efcff3ade
March 29, 2018
2
September 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
B360011B12632 25 B360011B12630 In Commercial Distribution BOX
B360011B12631 4 B360011B12630 In Commercial Distribution BOX
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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: 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

[?]
763-473-2533
sales@eyesurgin.com
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