AccessGUDID - DEVICE: ULTRASITE® (04046964181566)

GUDID

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

Primary DI Number: 04046964181566
Issuing Agency: GS1
Device Count: 50

Device Description: US3487F UNIVERSAL IV ADMIN SET

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 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.

Product Code	Product Code Name
FPA	Set, administration, intravascular

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling
No storage/handling found

Size Type Text
No Device Sizes

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: January 05, 2017
Commercial Distribution End Date:

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI Number: 04046964181559 CLOSE

Device Subject to Direct Marking (DM), but Exempt: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Phone: +1(800)227-2862
Email: BBMUS_Service.EmailOrders@bbraun.com