DEVICE: ULTRASITE® (04046964182815)

Device Identifier (DI) Information

ULTRASITE®
375111
In Commercial Distribution
375111
B. BRAUN MEDICAL INC.
04046964182815
GS1

20
002397347 *Terms of Use
Gravity Add-on Burette Set with 1 ULT RASITE® Injection site
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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
Burette intravenous administration set A collection of sterile devices designed to conduct fluids from an intravenous (IV) fluid container to a patient's venous system, that includes a calibrated burette for fluid volume measurement. The collection also typically includes tubing, connectors, clamps, and injection ports. It may be used for gravitational intravenous administration or with an infusion pump. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
FPA Set, administration, intravascular
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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
No Device Sizes
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Device Record Status

e59b5816-52bb-4b62-9ba9-e7cf0c84d461
September 21, 2018
3
January 05, 2017
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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: 04046964182808 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)227-2862
BBMUS_Service.EmailOrders@bbraun.com
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