AccessGUDID - DEVICE: ULTRASITE® (04046964181566)

GUDID

Device Identifier (DI) Information

Brand Name: ULTRASITE®
Version or Model: 352431
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 352431
Company Name: B. BRAUN MEDICAL INC.

Primary DI Number: 04046964181566
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 002397347 *Terms of Use

Device Description: US3487F UNIVERSAL IV ADMIN SET

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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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.

FDA Product Code

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Product Code	Product Code Name
FPA	Set, administration, intravascular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 91760c55-8dc1-43e9-8154-e865fe1054da
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: January 05, 2017