AccessGUDID - DEVICE: Element™ Test Strips (08809115908438)

GUDID

Device Identifier (DI) Information

Brand Name: Element™ Test Strips
Version or Model: IGM-0021B
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OSANG HEALTHCARE Co., Ltd.

Primary DI Number: 08809115908438
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 688195374 *Terms of Use

Device Description: 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:	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?
53303	Glucose IVD, kit, electrometry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K113670	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 36 and 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 0.3 Microliter

Device Record Status

Public Device Record Key: 8ba27134-6346-4b2f-8226-be3a60563bf8
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: December 11, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
08809115908445	2	08809115908438		In Commercial Distribution

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
NDC/NHRIC	8522-0000-23

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: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 866-878-7477
Email: xx@xx.xx

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