DEVICE: OneTouch Ping (00353885010207)

Device Identifier (DI) Information

OneTouch Ping
023-049
In Commercial Distribution

ANIMAS CORPORATION
00353885010207
GS1

1
968998641 *Terms of Use
OneTouch Ping Blood Glucose Management System For self-testing. For Quantitative measurement of glucose in whole blood. For in vitro diagnostic use only
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
Yes
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
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.
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FDA Product Code

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Product Code Product Code Name
LZG PUMP, INFUSION, INSULIN
CGA GLUCOSE OXIDASE, GLUCOSE
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FDA Premarket Submission

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

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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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
Storage Environment Temperature: between 41 and 86 Degrees Fahrenheit
Special Storage Condition, Specify: Store your test strips in their original vial only.
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Clinically Relevant Size

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

7ffcb6a3-cab2-4989-b090-379db924078e
July 06, 2018
3
September 13, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
20353885010201 15 00353885010207 In Commercial Distribution Shipper case
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(877)937-7867
XX@XX.XX
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