AccessGUDID - DEVICE: Trulink (10841522127359)

GUDID

Device Identifier (DI) Information

Brand Name: Trulink
Version or Model: NIBP Hoses and adapters
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 015-0313-01
Company Name: SPACELABS HEALTHCARE (WASHINGTON), INC

Primary DI Number: 10841522127359
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 145581588 *Terms of Use

Device Description: SAMPLE LINE,AGENT,W/SAMPLING TEE,10',50/BX

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":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
37061	Patient monitoring system module, multiple-gas	A small unit dedicated to the measurement of various gas concentrations, e.g., anaesthetic agents, oxygen (O2), carbon dioxide (CO2), in inspired and expired air obtained through a sampling tube connected to a main respiratory channel (mainstream) or a side-channel (sidestream) of a breathing circuit. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot and the parent device then operates as a mainframe computer displaying the parameters measured and provided by this module.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CBR	ANALYZER, GAS, NITROUS-OXIDE, GASEOUS PHASE (ANESTHETIC CONC.)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K112173	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 1.19mm/0.047in ID, 305 cm/10 ft length

Device Record Status

Public Device Record Key: 6201be2d-9e3b-4346-854c-7f54ac2bf4be
Public Version Date: June 25, 2024
Public Version Number: 3
DI Record Publish Date: September 06, 2019