AccessGUDID - DEVICE: Navigator Aesthetic Delivery System (00851634007008)

GUDID

Device Identifier (DI) Information

Brand Name: Navigator Aesthetic Delivery System
Version or Model: NAV-015
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: NAV-015
Company Name: CARTICEPT MEDICAL, INC.

Primary DI Number: 00851634007008
Issuing Agency: GS1
Commercial Distribution End Date: November 04, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 619025609 *Terms of Use

Device Description: No description.

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?
62520	Cylinder infusion pump	An electrically-powered device intended to facilitate the accurate and consistent administration of non-specific fluid medications from a standard infusion bag, syringe, and bottle, into a patient via intravenous, subcutaneous, arterial, epidural, and intracavital routes. Designed as an alternative to a standard infusion pump or syringe pump, it consists of a unit with a motor designed to drive pistons in a circular motion inside a replaceable cylinder, and which is connected to a disposable infusion administration set (e.g., tubing, filter, connectors, needle/catheter). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRN	Pump, Infusion

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
No Device Sizes

Device Record Status

Public Device Record Key: 5c3b215f-f0e9-492c-b1c7-61e9fb2b4478
Public Version Date: October 18, 2023
Public Version Number: 5
DI Record Publish Date: February 24, 2017