AccessGUDID - DEVICE: ReliOn Ultima (00681131060288)

GUDID

Device Identifier (DI) Information

Brand Name: ReliOn Ultima
Version or Model: 70055
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 70055
Company Name: WAL-MART STORES, INC.

Primary DI Number: 00681131060288
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 051957769 *Terms of Use

Device Description: Relion Utlima 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:	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?
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
JJX	Single (specified) analyte controls (assayed and unassayed)
NBW	SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
LFR	Glucose dehydrogenase, glucose

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K083223	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 -13 and 131 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2cd7ff8b-703f-4d1e-8469-a704c83f9116
Public Version Date: October 18, 2023
Public Version Number: 6
DI Record Publish Date: September 16, 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
30681131060289	4	00681131060288		In Commercial Distribution	Case

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
NDC/NHRIC	66004-6028-1

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

Customer Contact

[?]

Phone: +1(855)776-0662
Email: xx@xx.xx

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