AccessGUDID - DEVICE: RCK,37 PIN,5IN,1G,RAULAND R5 FEATURE BE (00840828143608)

GUDID

Device Identifier (DI) Information

Brand Name: RCK,37 PIN,5IN,1G,RAULAND R5 FEATURE BE
Version or Model: NCBED5
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 9610
Company Name: CURBELL MEDICAL PRODUCTS, INC.

Primary DI Number: 00840828143608
Issuing Agency: GS1
Commercial Distribution End Date: September 24, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 796452311 *Terms of Use

Device Description: RCK,37 PIN,5IN,1G,RAULAND R5 FEATURE BE

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:	No
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?
13299	Power line receptacle tester, electrical	An electronic instrument designed to measure and assess the electrical characteristics of a power line receptacle (e.g., an electrical wall receptacle or electrical wall socket). It is typically a plug-in device that can detect open (e.g., ground, live, neutral) lines and inverted connections (e.g., live on neutral); it usually includes a display and/or visual and audible alarms to indicate correct/faulty wiring and open connections. The device is used to assess the electrical characteristics of the most common healthcare facility electrical wall receptacles; some can also determine the tripping current of ground fault circuit interrupters by injecting a variable leakage current.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ILQ	System, Communication, Powered

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
No Device Sizes

Device Record Status

Public Device Record Key: 4667ccde-76dd-46d0-b5c8-ffe5e47128b3
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016