DEVICE: REPEATER (00085412482514)

Device Identifier (DI) Information

REPEATER
H938099ER
In Commercial Distribution
H938099ER
BAXTER CORPORATION ENGLEWOOD
00085412482514
GS1

1
078383477 *Terms of Use
REPEATER Pump, Refurbished Fluid Transfer Pump
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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
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.
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FDA Product Code

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Product Code Product Code Name
NEP SYSTEM/DEVICE, PHARMACY COMPOUNDING
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FDA Premarket Submission

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

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Handling Environment Temperature: between 41 and 104 Degrees Fahrenheit
Storage Environment Temperature: between 32 and 147.2 Degrees Fahrenheit
Special Storage Condition, Specify: Maximum Altitude Not to exceed 2000 m
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
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

0c1a62f8-3ec7-434b-bbba-8053f9e8a30b
March 29, 2018
2
September 23, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+1(800)933-0303
Medinfo_medproducts@baxter.com
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