AccessGUDID - DEVICE: Lifecard CF (10841522123313)

GUDID

Device Identifier (DI) Information

Brand Name: Lifecard CF
Version or Model: LCF; LCF_CBL; PXCABLES
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 19-7509
Company Name: SPACELABS HEALTHCARE (WASHINGTON), INC

Primary DI Number: 10841522123313
Issuing Agency: GS1
Commercial Distribution End Date: October 31, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 145581588 *Terms of Use

Device Description: LEADWIRES,SNAP,60CM,6SET,SAFETY,AHA HOLTER CODE

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?
47487	Electrical-only medical device connection cable, reusable	A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DSH	RECORDER, MAGNETIC TAPE, MEDICAL

FDA Premarket Submission

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

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: exactly 0 Percent (%) Relative Humidity
Storage Environment Temperature: exactly 0 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ed4f7c7e-32e3-496b-8b9b-13afcb36eeb1
Public Version Date: November 19, 2018
Public Version Number: 3
DI Record Publish Date: November 14, 2017