AccessGUDID - DEVICE: Animas Vibe (10840406100310)

GUDID

Device Identifier (DI) Information

Brand Name: Animas Vibe
Version or Model: 11620400
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 11620400
Company Name: ANIMAS CORPORATION

Primary DI Number: 10840406100310
Issuing Agency: GS1
Commercial Distribution End Date: July 21, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 968998641 *Terms of Use

Device Description: REP KIT, VIBE PEDS, P2 (OLDER), PGL, mg, US

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:	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?
64891	Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm	A portable electronic device designed to provide continuous or intermittent subcutaneous delivery of insulin to a patient with diabetes mellitus, incorporating software to receive glucose status data from a monitor/transmitter and to determine the delivery of insulin based on a continuous scalar algorithm. It may be badge-like, designed to adhere to skin or clothing or worn in a case attached to the belt or carried in a pocket and includes a reservoir, a pumping mechanism, and an infusion-rate controller. It may also allow additional manual administration/infusion and functionality to send data to a remote reporting system.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OYC	Pump, infusion, insulin, to be used with invasive glucose sensor

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
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Humidity: between 10 and 100 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: dd684f6e-d48c-4f44-9098-a6c9467e4b06
Public Version Date: August 04, 2021
Public Version Number: 4
DI Record Publish Date: November 16, 2015