AccessGUDID - DEVICE: Safety Adapter (00813079020134)

GUDID

Device Identifier (DI) Information

Brand Name: Safety Adapter
Version or Model: ADAP I
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ADAP I
Company Name: REMINGTON MEDICAL, INC.

Primary DI Number: 00813079020134
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 788472314 *Terms of Use

Device Description: The ADAP 1 is designed to interface between the recessed pin connectors used with Remington's cable models S-101-97, S-201-97, and FL-601-97, and the old models of external pulse generators (EPG) [old model is the acceptance of exposed 2mm pins]. Also, ADAP I is designed to be used with pacing system analyzers that have sockets that accept 2mm pins and 31.25mm separation between pins.

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):	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?
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
DSA	CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Area/Surface Area: 15.204 Square inch

Device Record Status

Public Device Record Key: aa47c917-b153-4b9b-86a4-a64eaabb3d43
Public Version Date: November 06, 2018
Public Version Number: 4
DI Record Publish Date: September 21, 2016