AccessGUDID - DEVICE: FreeStyle (00093815704287)

GUDID

Device Identifier (DI) Information

Brand Name: FreeStyle
Version or Model: 70428
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 70428
Company Name: ABBOTT DIABETES CARE INC

Primary DI Number: 00093815704287
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 200
Labeler D-U-N-S® Number*: 966390890 *Terms of Use

Device Description: FreeStyle Unistik 2

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
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
FMK	Lancet, blood

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: de5ac188-4a67-46b4-8b3c-763fa36b5abe
Public Version Date: August 03, 2018
Public Version Number: 1
DI Record Publish Date: July 03, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
30093815704288	30	00093815704287		In Commercial Distribution	Case

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
NDC/NHRIC	99073-0704-28

Unit of Use DI

[?]

Unit of Use DI Number: 10093815704284 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: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(888)522-5226
Email: xx@xx.xx

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