AccessGUDID - DEVICE: OneTouch Ping (00353885010207)

GUDID

Device Identifier (DI) Information

Brand Name: OneTouch Ping
Version or Model: 023-049
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ANIMAS CORPORATION

Primary DI Number: 00353885010207
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: OneTouch Ping Blood Glucose Management System For self-testing. For Quantitative measurement of glucose in whole blood. For in vitro diagnostic use only

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:	Yes
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?
62645	Glucose analyser IVD, home-use	An electrically-powered instrument intended to be used for the quantitative in vitro measurement of glucose levels in whole blood; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus. This analyser is typically included in a blood glucose monitoring system.	Active	false
53303	Glucose IVD, kit, electrometry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LZG	PUMP, INFUSION, INSULIN
CGA	GLUCOSE OXIDASE, GLUCOSE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K082590	000

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
Special Storage Condition, Specify: Keep away from direct sunlight and heat.
Special Storage Condition, Specify: Operating Altitude up to 10000 Feet
Special Storage Condition, Specify: Do not refrigerate
Special Storage Condition, Specify: Store your test strips in their original vial only.
Storage Environment Temperature: between 41 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Blood Glucose measurement Level mg/dL
Device Size Text, specify: Hematocrit 30 - 55%

Device Record Status

Public Device Record Key: 7ffcb6a3-cab2-4989-b090-379db924078e
Public Version Date: July 22, 2021
Public Version Number: 4
DI Record Publish Date: September 13, 2017