AccessGUDID - DEVICE: NOV - Novum IQ (05413765580895)

GUDID

Device Identifier (DI) Information

Brand Name: NOV - Novum IQ
Version or Model: 40700HUB
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 40700HUB
Company Name: BAXTER HEALTHCARE CORPORATION

Primary DI Number: 05413765580895
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005083209 *Terms of Use

Device Description: Infusion Pump Management unit, mobile

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?
36179	Multiple infusion pump management station	An electrically-powered unit designed for the bedside organization, management, operating control of infusion parameters, pump performance monitoring, and electrical supply of multiple infusion and/or syringe pumps that are being used simultaneously or sequentially. It typically consists of a tower rack with slots for the pumps, electrical sockets, infusion controls (e.g., automated relay changeovers between pumps), and alarms; some types have a user interface software/display, magnetic shielding properties for use during resonance imaging (MRI) procedures, and may be capable of detecting magnetic flux density to monitor pump performance during MRI.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FOX	STAND, INFUSION

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
Storage Environment Temperature: between -10 and 49 Degrees Celsius
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a5ed0f7e-53f5-4d2c-9c8d-bb62e0296064
Public Version Date: June 30, 2025
Public Version Number: 3
DI Record Publish Date: November 22, 2023

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)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)843-7867
Email: PumpSupport@Baxter.com

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