AccessGUDID - DEVICE: remede System Implantable Pulse Generator (00857688007001)

GUDID

Device Identifier (DI) Information

Brand Name: remede System Implantable Pulse Generator
Version or Model: 1001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: RESPICARDIA, INC.

Primary DI Number: 00857688007001
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 027887663 *Terms of Use

Device Description: remede System, implantable pulse generator for phrenic nerve stimulation

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	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: 8c13689e-88fc-45e8-afc7-8d9b9d9981ec
Public Version Date: July 01, 2024
Public Version Number: 3
DI Record Publish Date: April 30, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1-952-540-4471
Email: mlynn@zoll.com

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