AccessGUDID - DEVICE: Advanced Instruments Osmo1® Single-Sample Micro-Osmometer (00816068020542)

GUDID

Device Identifier (DI) Information

Brand Name: Advanced Instruments Osmo1® Single-Sample Micro-Osmometer
Version or Model: Osmo1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Osmo1
Company Name: ADVANCED INSTRUMENTS, INC.

Primary DI Number: 00816068020542
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 125006353 *Terms of Use

Device Description: With the Osmo1 Single-Sample Micro-Osmometer, we’ve bundled together accurate and reliable osmolality measurement with ease-of-use for efficient patient sample analysis. Easily maintain regulatory compliance while ensuring the security and integrity of patient data with the Osmo1. Best for labs that process 10 or fewer samples per day or prefer a direct-draw instrument.

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?
57854	Osmometric analyser IVD, semi-automated	A mains electricity (AC-powered) laboratory instrument intended to be used for the qualitative and/or quantitative determination of the osmotic concentration of a clinical specimen (e.g., urine, serum) by comparing its freezing-point depression curve, or vapour-pressure depression curve, with that of a standard solution. It is often used to assess an abnormal osmolar ratio which may indicate disease [e.g., renal disease, diabetes insipidus, secretion of abnormal levels of antidiuretic hormone (ADH)]. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JJM	Osmometer For Clinical Use

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: No
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: 0a6c135a-2481-416e-bf76-2825d3329e03
Public Version Date: September 29, 2020
Public Version Number: 1
DI Record Publish Date: September 21, 2020