AccessGUDID - DEVICE: Medtronic (06947437902535)

GUDID

Device Identifier (DI) Information

Brand Name: Medtronic
Version or Model: 5944RL
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SHENZHEN LAUNCH ELECTRICAL CO., LTD

Primary DI Number: 06947437902535
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 544922461 *Terms of Use

Device Description: The Model 5944RL rotatable connector is a pair of single use, disposable surgical cables with two adaptors. The cables are designed to connect a cardiovascular stimulating instrument to a cardiac pacing lead system.

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
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?
47143	Electrical-only medical device connection cable, single-use	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. Some types may include an electrical isolator to prevent electrical shocks, and/or a cable cover. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LDF	Electrode, Pacemaker, Temporary

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K241199	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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
No Device Sizes

Device Record Status

Public Device Record Key: 42b99229-f74d-4b61-9013-338437502b23
Public Version Date: February 24, 2025
Public Version Number: 2
DI Record Publish Date: February 08, 2025