DEVICE: ULTRASITE® (04046964181566)
Device Identifier (DI) Information
ULTRASITE®
352431
In Commercial Distribution
352431
B. BRAUN MEDICAL INC.
352431
In Commercial Distribution
352431
B. BRAUN MEDICAL INC.
US3487F UNIVERSAL IV ADMIN SET
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. |
FDA Product Code
[?]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 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
91760c55-8dc1-43e9-8154-e865fe1054da
March 29, 2018
2
January 05, 2017
March 29, 2018
2
January 05, 2017
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
04046964181559
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)227-2862
BBMUS_Service.EmailOrders@bbraun.com
BBMUS_Service.EmailOrders@bbraun.com