AccessGUDID - DEVICE: OneTouch Ultra2 (00353885011853)

GUDID

Device Identifier (DI) Information

Brand Name: OneTouch Ultra2
Version or Model: 024-046
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 024-046
Company Name: LifeScan Europe GmbH

Primary DI Number: 00353885011853
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 480240820 *Terms of Use

Device Description: OneTouch Ultra2 Blood Glucose Monitoring System.

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):	No
Over the Counter (OTC):	Yes
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?
62537	Glucose monitoring system IVD, home-use	A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NBW	System, Test, Blood Glucose, Over The Counter
CGA	Glucose Oxidase, Glucose

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: Store your test strips in the vial only
Special Storage Condition, Specify: Do not refrigerate
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between 43 and 111 Degrees Fahrenheit
Storage Environment Temperature: between 41 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

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

Device Record Status

Public Device Record Key: 83d6edaa-3d6b-42c6-b33a-3d33892e9f57
Public Version Date: September 02, 2022
Public Version Number: 2
DI Record Publish Date: March 12, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20353885011857	4	00353885011853		In Commercial Distribution	shipper case

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
NDC/NHRIC	53885-046-01

Unit of Use DI

[?]

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

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 8002278862
Email: XX@XX.XX

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES