OSMETTE III with Barcode Reader 5010B

GUDID 00850041049830

Precision Systems OSMETTE III osmometer with Barcode Reader

Precision Systems, Inc.

Osmometric analyser IVD Osmometric analyser IVD Osmometric analyser IVD Osmometric analyser IVD Osmometric analyser IVD Osmometric analyser IVD Osmometric analyser IVD Osmometric analyser IVD Osmometric analyser IVD Osmometric analyser IVD Osmometric analyser IVD Osmometric analyser IVD Osmometric analyser IVD Osmometric analyser IVD Osmometric analyser IVD Osmometric analyser IVD Osmometric analyser IVD

• Primary Device ID: 00850041049830
• NIH Device Record Key: 06d9d05f-5413-4f19-930c-6b9bdd63bb57
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSMETTE III with Barcode Reader
• Version Model Number: 5010B
• Catalog Number: 5010B
• Company DUNS: 001001676
• Company Name: Precision Systems, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 508-655-7010
• Email: precisionsystems@msn.com
• Phone: 508-655-7010
• Email: precisionsystems@msn.com
• Phone: 508-655-7010
• Email: precisionsystems@msn.com
• Phone: 508-655-7010
• Email: precisionsystems@msn.com
• Phone: 508-655-7010
• Email: precisionsystems@msn.com
• Phone: 508-655-7010
• Email: precisionsystems@msn.com
• Phone: 508-655-7010
• Email: precisionsystems@msn.com
• Phone: 508-655-7010
• Email: precisionsystems@msn.com
• Phone: 508-655-7010
• Email: precisionsystems@msn.com
• Phone: 508-655-7010
• Email: precisionsystems@msn.com
• Phone: 508-655-7010
• Email: precisionsystems@msn.com
• Phone: 508-655-7010
• Email: precisionsystems@msn.com
• Phone: 508-655-7010
• Email: precisionsystems@msn.com
• Phone: 508-655-7010
• Email: precisionsystems@msn.com
• Phone: 508-655-7010
• Email: precisionsystems@msn.com
• Phone: 508-655-7010
• Email: precisionsystems@msn.com
• Phone: 508-655-7010
• Email: precisionsystems@msn.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850041049830 [Primary]

FDA Product Code

• JJM: Osmometer For Clinical Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-23
• Device Publish Date: 2023-10-14

Devices Manufactured by Precision Systems, Inc.

• 00850041049014 - Precision Systems 100 mOsm Osmometry Standard: 2023-10-23 Precision Systems 100 mOsm Osmometry Standard, 125 mL bottle
• 00850041049021 - Precision Systems 200 mOsm Osmometry Standard: 2023-10-23 Precision Systems 200 mOsm Osmometry Standard, 250 mL bottle
• 00850041049038 - Precision Systems 300 mOsm Osmometry Standard: 2023-10-23 Precision Systems 300 mOsm Osmometry Standard, 125 mL bottle
• 00850041049045 - Precision Systems 400 mOsm Osmometry Standard: 2023-10-23 Precision Systems 400 mOsm Osmometry Standard, 250 mL bottle
• 00850041049052 - Precision Systems 500 mOsm Osmometry Standard, 125 mL bottle: 2023-10-23 Precision Systems 500 mOsm Osmometry Standard, 125 mL bottle
• 00850041049069 - Precision Systems 600 mOsm Osmometry Standard: 2023-10-23 Precision Systems 600 mOsm Osmometry Standard, 250 mL bottle
• 00850041049076 - Precision Systems 700 mOsm Osmometry Standard: 2023-10-23 Precision Systems 700 mOsm Osmometry Standard, 250 mL bottle
• 00850041049083 - Precision Systems 800 mOsm Osmometry Standard: 2023-10-23 Precision Systems 800 mOsm Osmometry Standard, 250 mL bottle