FDA.reportPublic FDA data

Advanced Instruments 30 µL Pipet

Primary DI
00816068020566
Brand
Advanced Instruments 30 µL Pipet
Company
ADVANCED INSTRUMENTS, INC.
Model
222820
Catalog number
222820
Device description
Advanced Instruments pipettes are used to facilitate sample management while using Advanced Instruments osmometers
Published
2020-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJMOsmometer For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJMOsmometer For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816068020566PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816068020566008160680205668160680205660816068020566

GMDN Terms#

Term, Definition table
TermDefinition
Osmometric analyser IVD, automatedA 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, tears, sweat) 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 minimal technician involvement and complete automation of all procedural steps.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+17813209000Orders@aicompanies.com

Regulatory Flags#

DUNS number
125006353
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816068020795Advanced Instruments OsmoPRO Multi Sample Micro Osmometer Sample Tubes2028252028252020-09-21
00816068020825Advanced Instruments Model 3250 Single-Sample Osmometer Sample Tubes, Box of 5003LA8253LA8252020-09-21
00816068020979Advanced Instruments 300 mOsm Calibration Std - 2mL Ampule - Pkg 103MA0033MA0032020-09-21
00816068020269Advanced Instruments Clinitrol 290 Reference Solution, 5mL Ampule, Pkg 103LA0293LA0292020-09-21
00816068020306Advanced Instruments Calibration Standard 2000 mOsm - 2mL Ampule - Pkg 103MA2003MA2002020-09-21
00816068020313Advanced Instruments 50 mOsm Calibration Standard - 2mL Ampule - Pkg 103MA0053MA0052020-09-21
00816068020368Advanced Instruments Clinitrol 290 Reference Solution - 2mL Ampule - Pkg 103MA0293MA0292020-09-21
00816068020375Advanced Instruments 850 mOsm Calibration Standard - 2mL Ampule - Pkg 103MA0853MA0852020-09-21
00816068020436Advanced Instruments 100 mOsm Calibration Standard - 5mL Ampule - Pkg 103LA0113LA0112020-09-21
00816068020443Advanced Instruments 1500 mOsm Calibration Standard - 5mL Ampule - Pkg 103LA1513LA1512020-09-21
00816068020450Advanced Instruments 500 mOsm Calibration Standard - 5mL Ampule - Pkg 103LA0513LA0512020-09-21
00816068020467Advanced Instruments 900 mOsm Calibration Standard - 5mL Ampule - Pkg 103LA0913LA0912020-09-21
00816068020474Advanced Instruments 2000 mOsm Calibration Standard - 5mL Ampule - Pkg 103LA2013LA2012020-09-21
00816068020603Advanced Instruments A2O Advanced Automated Osmometer Samples Tubes, Box of 5002002232002232020-09-21
00816068020740Advanced Instruments 3000 mOsm Calibration Standard - 5mL Ampule - Pkg 103LA3013LA3012020-09-21
00816068020757Advanced Instruments 0 mOsm Calibration Standard - 2mL Ampule - Pkg 103MA0003MA0002020-09-21
00816068020764Advanced Instruments 200 mOsm Calibration Standard - 2mL Ampule - Pkg 103MA0203MA0202020-09-21
00816068020771Advanced Instruments 400 mOsm Calibration Standard - 2mL Ampule - Pkg 103MA0403MA0402020-09-21
00816068020788Advanced Instruments 1000 mOsm Calibration Standard - 2mL Ampule - Pkg 103MA1003MA1002020-09-21
00816068020993Advanced Instruments 4000 mOsm Calibration Std - 2mL Ampule - Pkg 103MA4003MA4002020-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850041049144Probe for Micro-OSMETTEPrecision Systems, Inc.JJM2023-10-14
00850041049168OSMETTE III with Barcode Reader, 220VPrecision Systems, Inc.JJM2023-10-14
00850041049175Probe for Multi-OSMETTE Precision Systems, Inc.JJM2023-10-14
00850041049182Multi-OSMETTE, Extended Range, 220VPrecision Systems, Inc.JJM2023-10-14
00850041049199OSMETTE XL, 105VAC, JapanPrecision Systems, Inc.JJM2023-10-14
00850041049212OSMETTE Sample Tubes, 2 ml, 12/pkPrecision Systems, Inc.JJM2023-10-14
00850041049229OSMETTE Sample Tubes, 0.2 ml, 12/pkPrecision Systems, Inc.JJM2023-10-14
00850041049236Micro-OSMETTE Sample Tubes, 50 ulPrecision Systems, Inc.JJM2023-10-14
00850041049243OSMETTE XL, 105VAC, Japan, specialPrecision Systems, Inc.JJM2023-10-14
00850041049267OSMETTE Pipettor, 50 ulPrecision Systems, Inc.JJM2023-10-14
00850041049281Clearview Disp Sample Tubes, 0.2 mlPrecision Systems, Inc.JJM2023-10-14
00850041049311CRYETTE Stir Wires, for 2 ml tubes, 4/pkPrecision Systems, Inc.JJM2023-10-14
00850041049328OSMETTE Stir Wires, for 0.2 & 2.0 samples, 4/pkgPrecision Systems, Inc.JJM2023-10-14
00850041049335Micro-OSMETTE Stir Wires for 50 ul samples, 4/pkgPrecision Systems, Inc.JJM2023-10-14
00850041049366OSMETTE III 10 ul Pipet Piston 2/pkPrecision Systems, Inc.JJM2023-10-14
00850041049373OSMETTE III Plunger Tip WirePrecision Systems, Inc.JJM2023-10-14
00850041049380OSMETTE Sample Tubes, 30 ulPrecision Systems, Inc.JJM2023-10-14
00850041049410OSMETTE Sample Tube Rack for 2.0 & 0.2 mlPrecision Systems, Inc.JJM2023-10-14
00850041049427Multi-OSMETTE Carousel, SparePrecision Systems, Inc.JJM2023-10-14
00850041049434Multi-OSMETTE Evaporation ShieldPrecision Systems, Inc.JJM2023-10-14
00850041049441OSMETTE Sample Tube Rack, 50 ulPrecision Systems, Inc.JJM2023-10-14
00850041049489OSMETTE III Pipette Tips & CLEANETTEs, 1/M ea/pkPrecision Systems, Inc.JJM2023-10-14
00850041049502OSMETTE Probe 0.2 & 2.0 mlPrecision Systems, Inc.JJM2023-10-14
00850041049519Touch Micro-OSMETTE ProbePrecision Systems, Inc.JJM2023-10-14
00850041049526OSMETTE III ProbePrecision Systems, Inc.JJM2023-10-14
00850041049533OSMETTE Sample Tubes, 30 ulPrecision Systems, Inc.JJM2023-10-14
0085004104954010 ul Pipettor for OSMETTE IIIPrecision Systems, Inc.JJM2023-10-14
00850041049557OSMETTE Pipette Tips 1000/pkg 30 - 50 ulPrecision Systems, Inc.JJM2023-10-14
00850041049564OSMETTE Printer RibbonPrecision Systems, Inc.JJM2023-10-14
00850041049571OSMETTE Bath Liquid, 250mlPrecision Systems, Inc.JJM2023-10-14