RightSpotpH®

GUDID 40861145002605

Small Bore Indicator

RIGHTBIO/METRICS INC.

pH meter IVD

• Primary Device ID: 40861145002605
• NIH Device Record Key: 1560e996-55f1-41b4-b42a-1774f72968ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RightSpotpH®
• Version Model Number: RSSB001
• Company DUNS: 964861012
• Company Name: RIGHTBIO/METRICS 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 480-466-0041
• Email: info@RightBioMetrics.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 52 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 52 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00861145002607 [Primary]
GS1	20861145002601 [Package]; Contains: 00861145002607; Package: Inner Carton [10 Units]; In Commercial Distribution
GS1	40861145002605 [Package]; Contains: 00861145002607; Package: Master Case [350 Units]; In Commercial Distribution

FDA Product Code

• JLL: Tubeless Analysis, Gastric Acidity

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: 2018-12-11
• Device Publish Date: 2018-11-10