SIGMA Spectrum Infusion Pump

Basic Information

• Brand Name: SIGMA Spectrum Infusion Pump
• Primary DI: 00085412498683
• Version / Model: 35700BAX2
• Catalog Number: 35700BAX2
• Company Name: BAXTER INTERNATIONAL INC.
• Labeler DUNS: 079209157
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 6
• Public Version Date: 2023-04-27
• Public Version Status: Update
• Public Device Record Key: 753fa5b0-6dba-42d3-8deb-f49e680e52fd

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PHC	Infusion safety management software	General Hospital	880.5725	2
FRN	Pump, infusion	General Hospital	880.5725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
13215	Bedside infusion pump, single-channel	An electrically-powered, non-ambulatory (bedside) device designed to facilitate the accurate and consistent administration of a single drug/solution which can be delivered via intravenous, subcutaneous, arterial, epidural, and intracavital routes using a dedicated infusion set; it is not dedicated to a specific treatment type. It is used to supply higher pressures than those provided by gravity infusion sets or infusion controllers (e.g., typical flow range of 1 to 999 ml/hour) and delivers solutions from a standard infusion bag or bottle of fluid. It is intended primarily for use at the bedside but typically has internal batteries that enable operation, e.g., during transportation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00085412498683	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K133801	000
K230022	000

Storage Conditions

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