FDA.reportPublic FDA data

OneTouch Ping

Primary DI
00353885010207
Brand
OneTouch Ping
Company
ANIMAS CORPORATION
Model
023-049
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
Published
2017-09-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CGAGLUCOSE OXIDASE, GLUCOSE
LZGPUMP, INFUSION, INSULIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGAGlucose Oxidase, GlucoseClinical Chemistry2
LZGPump, Infusion, InsulinGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082590000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082590000SYMPHONY METER REMOTELifescan, Inc.2008-12-17LZG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20353885010201PackageGS115Not in Commercial Distribution
00353885010207PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2035388501020120353885010201
00353885010207003538850102073538850102070353885010207

GMDN Terms#

Term, Definition table
TermDefinition
Glucose analyser IVD, home-useAn 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not refrigerate
Special Storage Condition, Specify00Keep away from direct sunlight and heat.
Special Storage Condition, Specify00Operating Altitude up to 10000 Feet
Special Storage Condition, Specify00Store your test strips in their original vial only.
Storage Environment Temperature41 Degrees Fahrenheit86 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(877)937-7867XX@XX.XX

Regulatory Flags#

DUNS number
968998641
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10840406100051Animas Vibe11451100114511002015-09-17
10840406100013Animas Vibe11420000114200002015-09-17
10840406100136Animas 2.0 mL Cartridge10012402100124022015-09-17
10840406100334Animas Vibe11651000116510002015-11-16
10840406100570Animas Vibe11851000118510002016-03-14
10840406100839OneTouch Ping10143500101435002016-08-18
10840406100976OneTouch Ping10543100105431002016-08-18
10840406103106Animas Vibe13920000139200002018-01-15
10840406103823Animas Vibe10255100102551002017-09-21
10840406100112Animas Vibe11420000114200002015-09-17
10840406100020Animas Vibe11420400114204002015-09-17
10840406100037Animas Vibe11420200114202002015-09-17
10840406100044Animas Vibe11451000114510002015-09-17
10840406100068Animas Vibe11451400114514002015-09-17
10840406100075Animas Vibe11451500114515002015-09-17
10840406100082Animas Vibe11451200114512002015-09-17
10840406100099Animas Vibe11420100114201002015-09-17
10840406100105Animas Vibe11420500114205002015-09-17
10840406100129Animas 2.0 mL Cartridge10012402100124022015-09-17
10840406100181Animas Vibe11551000115510002015-11-24

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Primary DI, Brand, Company table
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04719869706942Tyson Bio AC500 PRO Control Solution (Level 1) (FDA)TYSON BIORESEARCH INC.CGA2026-07-13
04719869706959Tyson Bio AC500 PRO Control Solution (Level 3) (FDA)TYSON BIORESEARCH INC.CGA2026-07-13
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