DEVICE: Outlook® (04046964186523)
Device Identifier (DI) Information
Outlook®
621-200ES
In Commercial Distribution
621-200ES
B. BRAUN MEDICAL INC.
621-200ES
In Commercial Distribution
621-200ES
B. BRAUN MEDICAL INC.
Large Volume Infusion Pump System with Drug Library and Barcoding
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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 |
---|---|
General-purpose infusion pump, line-powered | A mains electricity (AC-powered) device designed to facilitate the accurate and consistent administration of drugs and solutions which can be delivered via intravenous, subcutaneous, arterial, epidural, and intracavital routes using a dedicated infusion set. It is used to supply higher pressures than those provided by manually clamped gravity infusion sets or infusion controllers. The device has a typical flow range of 1 to 999 ml/hour and delivers solutions from a standard infusion bag or bottle of fluid. It typically has internal batteries that enable operation for a short period when no mains electricity is available (e.g., during transportation or a power outage). |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FRN | Pump, infusion |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: FRAGILE MEDICAL INSTRUMENT |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
1c52864c-428f-41b0-9f5e-121e9f338b6e
December 03, 2018
4
September 23, 2016
December 03, 2018
4
September 23, 2016
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:
No Unit of Use DI Numbers Found
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