OneTouch Ping - OTP PUMP W/O KIT, LGN, US - ANIMAS CORPORATION

Duns Number:968998641

Device Description: OTP PUMP W/O KIT, LGN, US

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More Product Details

Catalog Number

10543500

Brand Name

OneTouch Ping

Version/Model Number

10543500

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 21, 2020

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

LZG

Product Code Name

PUMP, INFUSION, INSULIN

Device Record Status

Public Device Record Key

88b942be-49cd-4c34-956f-61f77279dc9a

Public Version Date

August 04, 2021

Public Version Number

5

DI Record Publish Date

August 18, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ANIMAS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 12
3 A medical device with high risk that requires premarket approval 45