AccessGUDID - DEVICE: BAROSTIM NEO (00859144004432)

GUDID

Device Identifier (DI) Information

Brand Name: BAROSTIM NEO
Version or Model: 2102
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 100054-202
Company Name: CVRX, INC.

Primary DI Number: 00859144004432
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 052373680 *Terms of Use

Device Description: BAROSTIM NEO Model 2102 Implantable Pulse Generator (US Commercial)

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:	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?
35369	Baroreceptor electrical stimulation system	An assembly of devices intended to apply electrical stimuli to baroreceptors, within the carotid sinus, as therapy for hypertension; it may additionally be intended to stimulate baroreceptors outside of the carotid sinus and as therapy for other disorders (e.g., heart failure, chronic kidney disease) in the absence of hypertension. It includes an implantable assembly [i.e., pulse generator and electrode(s)/lead(s)], an external programmer intended to communicate with the pulse generator wirelessly, and may include other supportive devices (e.g., computer, software, disposable implantation devices).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
DSR	Stimulator, Carotid Sinus Nerve

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: 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: eee607e1-731e-401b-935c-e1af1e4e674a
Public Version Date: August 30, 2019
Public Version Number: 1
DI Record Publish Date: August 22, 2019

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: 7634167457
Email: acrouse@cvrx.com

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