AccessGUDID - DEVICE: Vital Signs™ (10889483591420)

GUDID

Device Identifier (DI) Information

Brand Name: Vital Signs™
Version or Model: 9446-909
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9446-909
Company Name: AirLife Finland Oy

Primary DI Number: 10889483591420
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 368457563 *Terms of Use
Previous DI: 10190752181366

Device Description: Vital Signs™ cardiac output injectate bath probe for GE monitors, 1.8 m/6 ft

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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":	Yes
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?
62220	Injectate temperature probe	A non-sterile, non-patient contact device intended to be connected to a parent temperature display/monitor (not included) to measure the temperature of a vascular injectate solution (and/or injectate cooling bath) prior to its introduction into the vasculature (e.g., as part of thermodilution-based cardiac output monitoring); it is not intended to contact the injectate directly. It is typically a metal probe with a sensor and connection cable. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQE	Catheter, Oximeter, Fiber-Optic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K915073	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 Temperature: between -22 and 140 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f744c2a1-b18c-44e1-bd4f-5dedbb1b7bd4
Public Version Date: April 10, 2025
Public Version Number: 1
DI Record Publish Date: April 02, 2025