AccessGUDID - DEVICE: FreeStyle (00699073121011)

GUDID

Device Identifier (DI) Information

Brand Name: FreeStyle
Version or Model: 12101
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 12101
Company Name: ABBOTT DIABETES CARE INC

Primary DI Number: 00699073121011
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 966390890 *Terms of Use

Device Description: FreeStyle Blood Glucose Test Strips

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):	Yes
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?
62643	Multiple clinical chemistry analyte monitoring system IVD, home-use	A collection of devices including a portable, electrically-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 together for the quantitative measurement of multiple clinical chemistry analytes in a clinical specimen. Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes. It is intended 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NBW	SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
LFR	Glucose dehydrogenase, glucose

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092638	000

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
Storage Environment Temperature: between 40 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d6685a83-a1a8-4886-a997-d4dfc2c5e086
Public Version Date: October 18, 2023
Public Version Number: 5
DI Record Publish Date: September 02, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
40699073121019	12	00699073121011		In Commercial Distribution	Case
30699073121012	12	00699073121011		In Commercial Distribution	Case

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
NDC/NHRIC	99073-0121-01

Unit of Use DI

[?]

Unit of Use DI Number: 10699073121018 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: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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