N/A

GUDID 60888937900011

SEMEN ANALYSIS KIT

ORIGIO INC.

Microscope counting chamber IVD

• Primary Device ID: 60888937900011
• NIH Device Record Key: f43514ab-d227-4e8d-9b3a-f3010861cafa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: 07-SAK
• Company DUNS: 787068394
• Company Name: ORIGIO INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	60888937900011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K915229

FDA Product Code

• POV: Semen Analysis Device

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-22

On-Brand Devices [N/A]

• 60888937907805: O-RING KIT WITH COLLET
• 60888937907799: O-RING KIT WITH COLLET
• 60888937900028: SEMEN ANALYSIS KIT
• 60888937900011: SEMEN ANALYSIS KIT
• 20888937911576: BIOPSY MICROPIPETS
• 20888937911569: BIOPSY MICROPIPETS
• 20888937911033: COUNTING CHAMBER
• 20888937910807: ICSI MICROPIPETS
• 20888937910784: BIOPSY MICROPIPETS
• 20888937910777: HOLDING MICROPIPETS
• 20888937910760: ICSI MICROPIPETS
• 20888937907814: PLUNGER REPLACEMENT
• 20888937907777: N/A
• 20888937907685: PZD MICROPIPETS
• 20888937907661: PZD MICROPIPETS
• 20888937907609: PZD MICROPIPETS
• 20888937907548: PZD MICROPIPETS
• 20888937907531: PZD MICROPIPETS
• 20888937907517: PZD MICROPIPETS
• 20888937907500: PZD MICROPIPETS
• 20888937907487: PZD MICROPIPETS
• 20888937907463: PZD MICROPIPETS
• 20888937905391: HOLDING MICROPIPETS
• 20888937905377: HOLDING MICROPIPETS
• 20888937905353: HOLDING MICROPIPETS
• 20888937905308: HOLDING MICROPIPETS
• 20888937905292: HOLDING MICROPIPETS
• 20888937905278: HOLDING MICROPIPETS
• 20888937905230: HOLDING MICROPIPETS
• 20888937905216: HOLDING MICROPIPETS
• 20888937905193: HOLDING MICROPIPETS
• 20888937905186: HOLDING MICROPIPETS
• 20888937905155: HOLDING MICROPIPETS
• 20888937905131: HOLDING MICROPIPETS
• 20888937905117: HOLDING MICROPIPETS
• 20888937905094: HOLDING MICROPIPETS
• 20888937905087: HOLDING MICROPIPETS
• 20888937905056: HOLDING MICROPIPETS
• 20888937905032: HOLDING MICROPIPETS
• 20888937905018: HOLDING MICROPIPETS
• 20888937904998: HOLDING MICROPIPETS
• 20888937904981: HOLDING MICROPIPETS
• 20888937904967: HOLDING MICROPIPETS
• 20888937904929: HOLDING MICROPIPETS
• 20888937904912: HOLDING MICROPIPETS
• 20888937904882: HOLDING MICROPIPETS
• 20888937904868: HOLDING MICROPIPETS
• 20888937904851: HOLDING MICROPIPETS
• 20888937904837: HOLDING MICROPIPETS
• 20888937904806: HOLDING MICROPIPETS