AccessGUDID - DEVICE: OneTouch Ping (10840406101058)

GUDID

Device Identifier (DI) Information

Brand Name: OneTouch Ping
Version or Model: 10543200
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 10543200
Company Name: ANIMAS CORPORATION

Primary DI Number: 10840406101058
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: OTP PUMP W/O KIT, SIL, 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
LZG	PUMP, INFUSION, INSULIN

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 Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Humidity: between 10 and 100 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 60629ed4-ce63-4da6-a26a-c4138c6beb61
Public Version Date: August 04, 2021
Public Version Number: 5
DI Record Publish Date: August 18, 2016