AccessGUDID - DEVICE: respistim R Stimulation Lead, Inline Connector (00857688007438)

GUDID

Device Identifier (DI) Information

Brand Name: respistim R Stimulation Lead, Inline Connector
Version or Model: 3602
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: RESPICARDIA, INC.

Primary DI Number: 00857688007438
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 027887663 *Terms of Use

Device Description: Respiratory stimulation lead; respistim R, 60cm; 25mm distal spring length; 24 mm distal coil diameter; hexapolar; distal spiral bias, inline connector

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":	No
For Single-Use:	Yes
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?
62679	Transvenous phrenic nerve electrical stimulation control unit	An electrically-powered device designed to configure/deliver stimulation of the phrenic nerve, via a transvenous electrode, to cause contraction of the diaphragm in conjunction with mechanical ventilation to assist earlier ventilation weaning. It consists of a pulse generator and a graphical user interface to adjust settings.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PSR	Implanted Phrenic Nerve Stimulator For Central Sleep Apnea

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P160039	006

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: fa974ad2-3bf2-49c2-90ef-1e99a8e00121
Public Version Date: August 30, 2021
Public Version Number: 1
DI Record Publish Date: August 20, 2021