AccessGUDID - DEVICE: Novum IQ (00197886002300)

GUDID

Device Identifier (DI) Information

Brand Name: Novum IQ
Version or Model: 40800BAXUSL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 40800BAXUSL
Company Name: BAXTER HEALTHCARE CORPORATION

Primary DI Number: 00197886002300
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005083209 *Terms of Use

Device Description: The Novum IQ Syringe Pump is software controlled Syringe infusion pump system that provides delivery of fluids into a patient in a controlled manner, as identified in 21 CFR 880.5725.

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?
13217	Bedside syringe pump	A mains electricity (AC-powered) non-ambulatory device designed to precisely drive the plunger of a syringe down its barrel to infuse a solution when it must be administered with a high degree of volume accuracy and rate consistency. Because of the lower flow settings and flow resolution (e.g., 0.1 ml/hr), it is especially appropriate for neonatal, infant, and critical care applications in which small volumes of concentrated drugs are to be delivered over an extended period. It can also be used to administer epidural analgesia. It will typically have internal batteries to allow operation for a short period of time when no line power is available (e.g., during transport or a power outage).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LZH	Pump, infusion, enteral
FRN	Pump, infusion

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K242390	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
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Special Storage Condition, Specify: Keep Dry. Keep away from Sunlight.
Storage Environment Temperature: between -10 and 49 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d2c84a6c-6d35-4d7e-ab59-e779808c3369
Public Version Date: July 15, 2025
Public Version Number: 1
DI Record Publish Date: July 07, 2025