AccessGUDID - DEVICE: OptiScanner 5000 Disposable Cartridge (00850003892054)

GUDID

Device Identifier (DI) Information

Brand Name: OptiScanner 5000 Disposable Cartridge
Version or Model: 5000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OPTISCAN BIOMEDICAL CORPORATION

Primary DI Number: 00850003892054
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 939218384 *Terms of Use

Device Description: OptiScanner Disposable Cartridge

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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):	Yes
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?
58436	Point-of-care blood glucose monitoring system	An assembly of devices intended to be operated by a healthcare professional to continually measure patient blood glucose at the point-of-care in a healthcare facility. It is continuously connected to the patient during use and typically consists of a line-powered control unit, with user interface and rechargeable battery, containing a spectrometer to quantitatively measure glucose concentration in received plasma samples; a sterile, single-use cartridge connected to the patient via a venous catheter designed to withdraw a blood sample at intervals, convert it to plasma, and transport it to the control unit for analysis; a heparin syringe; and a sterile cap to protect the patient connector.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PYV	Hospital Continuous Glucose Monitoring System
LZF	Pump, Infusion, Analytical Sampling

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K162042	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Do not expose to rain or water
Special Storage Condition, Specify: Do not expose to direct sunlight
Storage Environment Temperature: between 5 and 35 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7179050a-2c2e-4d0a-814c-4fc71f242993
Public Version Date: September 09, 2020
Public Version Number: 2
DI Record Publish Date: December 31, 2018