DEVICE: SIGMA Spectrum Infusion Pump (00085412498683)

Device Identifier (DI) Information

SIGMA Spectrum Infusion Pump
35700BAX2
In Commercial Distribution
35700BAX2
BAXTER INTERNATIONAL INC.
00085412498683
GS1

1
079209157 *Terms of Use
The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library provides delivery of fluids in a controlled manner. It is a software controlled electromechanical device used for infusion of pharmaceutical drugs, blood, blood products and mixtures of patient therapy through administration sets.
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Device Characteristics

MR Unsafe
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).
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FDA Product Code

[?]
Product Code Product Code Name
PHC Infusion safety management software
FRN Pump, infusion
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K133801 000
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Sterilization

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

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Storage and Handling
Special Storage Condition, Specify: Device Stored with Wireless Battery from 10 to 90 percent relative humidity
Special Storage Condition, Specify: Device Stored with Wireless Battery from -10 to 49 degrees celsius
Special Storage Condition, Specify: Device Stored with Standard Battery from -10 to 49 degrees celsius
Special Storage Condition, Specify: Device Stored with Wireless Battery from 14 to 120 degrees fahrenheit
Special Storage Condition, Specify: Remove the battery module from the pump when storing for extended periods of time
Special Storage Condition, Specify: Device Stored with Standard Battery from 10 to 90 percent relative humidity
Special Storage Condition, Specify: Device Stored with Standard Battery from 14 to 120 degrees fahrenheit
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

753fa5b0-6dba-42d3-8deb-f49e680e52fd
July 06, 2018
3
September 24, 2016
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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
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Secondary DI

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

[?]
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
No
No CLOSE

Customer Contact

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