AccessGUDID - DEVICE: SIGMA Spectrum Infusion Pump (00085412498683)

GUDID

Device Identifier (DI) Information

Brand Name: SIGMA Spectrum Infusion Pump
Version or Model: 35700BAX2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 35700BAX2
Company Name: BAXTER INTERNATIONAL INC.

Primary DI Number: 00085412498683
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079209157 *Terms of Use

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

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PHC	Infusion safety management software
FRN	Pump, infusion

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K133801	000
K230022	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 753fa5b0-6dba-42d3-8deb-f49e680e52fd
Public Version Date: April 27, 2023
Public Version Number: 6
DI Record Publish Date: September 24, 2016