FDA.reportPublic FDA data

OneTouch Ping

Primary DI
20353885011673
Brand
OneTouch Ping
Company
LifeScan Europe GmbH
Model
023-049
Catalog number
023-049
Device description
OneTouch Ping Blood Glucose Management System. Meter Remote
Published
2017-12-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZGPUMP, INFUSION, INSULIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
20353885011673PackageGS115In Commercial Distribution
00353885011679PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2035388501167320353885011673
00353885011679003538850116793538850116790353885011679

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
Needle Gauge28Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not refrigerate
Storage Environment Temperature086 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
480240820
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00353885000512OneTouch Ultramini021-211021-2112017-09-13
00353885001311OneTouch Ultramini021-422021-4222017-09-13
00353885002684OneTouch Ultramini021-913021-9132017-09-13
00353885007719OneTouch Verio IQ022-268022-2682017-09-13
00353885007726OneTouch Verio022-269022-2692017-09-13
00353885007733OneTouch Verio022-270022-2702017-09-13
00353885008723OneTouch Verio022-658022-6582017-09-13
00353885008853OneTouch Ultra2021-100021-1002017-09-13
00353885009751OneTouch Verio022-898022-8982017-09-13
00353885009768OneTouch Verio022-899022-8992017-09-13
00353885010016OneTouch Ultra2022-965022-9652017-09-13
00353885010030OneTouch Verio022-978022-9782017-09-13
00353885010481OneTouch Verio023-061023-0612017-09-13
00353885010979OneTouch Verio Flex023-270023-2702017-09-13
00353885011556OneTouch Verio011-817011-8172017-09-13
00353885011563OneTouch Ultra Blue011-424011-4242017-09-13
00353885011570OneTouch Ultra Blue011-424011-4242017-09-13
00353885011679OneTouch Ping023-049023-0492017-12-14
00353885011761OneTouch Verio Flex023-932023-9322018-06-27
00353885012034OneTouch Verio024-174024-1742020-04-12

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Primary DI, Brand, Company table
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10850037806000MODD1 Adhesive Pad, 10 PackModular Medical, Inc.LZG2025-07-11
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00850037806119MODD1 Starter KitModular Medical, Inc.LZG2025-07-11
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