DEVICE: REPEATER (00085412482521)
Device Identifier (DI) Information
REPEATER
H938099E
In Commercial Distribution
H938099E
BAXTER HEALTHCARE CORPORATION
H938099E
In Commercial Distribution
H938099E
BAXTER HEALTHCARE CORPORATION
REPEATER Pump, Fluid Transfer Pump
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
17459 | Intravenous solution compounder |
A device that is typically exclusively used in the clinical pharmacy or a manufacturing plant for the production of intravenous (IV) fluids. These fluids will typically be distributed using the appropriate containers.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NEP | SYSTEM/DEVICE, PHARMACY COMPOUNDING |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Maximum Relative Humidity 80 percent up to 87.8 degrees F, 31 degrees C, decreasing linearly to 50 percent at 104 degrees F, 40 degrees C |
Handling Environment Temperature: between 41 and 104 Degrees Fahrenheit |
Storage Environment Temperature: between 32 and 147.2 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
c01a2afa-f256-4b9e-a970-071c5721f40b
July 21, 2023
6
September 23, 2016
July 21, 2023
6
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)422-9837
cfs_customer_service@baxter.com
cfs_customer_service@baxter.com