Prosphyg™ 760-11ACMKOIQ

GUDID 00843515234450

PROSPHYG Aneroid Sphyg,Adult, Camouflage, KOI PL, LF

AMERICAN DIAGNOSTIC CORP

Ophthalmic/otologic diagnostic set

• Primary Device ID: 00843515234450
• NIH Device Record Key: 3e4397a2-9277-49cb-b4b1-2d8316520861
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prosphyg™
• Version Model Number: 760-11ACMKOIQ
• Catalog Number: 760-11ACMKOIQ
• Company DUNS: 108999095
• Company Name: AMERICAN DIAGNOSTIC CORP
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: true

Customer Support Contacts

• Phone: 1-800-232-2670
• Email: info@adctoday.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00843515234450 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K950914

FDA Product Code

• HLJ: Ophthalmoscope, Battery-Powered

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: 2016-09-21

On-Brand Devices [Prosphyg™]

• 00634782595975: Pro's Combo 768/609 Kit,Adult, Royal Blue, LF
• 00634782595968: Pro's Combo 768/609 Kit,Adult, Navy, LF
• 00634782595951: Pro's Combo 768/609 Kit,Adult, Purple, LF
• 00634782595944: Pro's Combo 768/609 Kit,Adult, Teal, LF
• 00634782595937: Pro's Combo 768/609 Kit,Adult, Black, LF
• 00634782595319: Standard Aneroid Sphyg,Adult, Navy, PH PL, LF
• 00634782595258: BP Kit w/METALITE Penlight,Adult, Magenta
• 00634782587543: BP Kit w/METALITE Penlight,Adult, Black
• 00634782085483: Sphyg/Scope Kit,Adult, Navy, no logo, LF
• 00634782066956: PROSPHYG Aneroid Sphyg,Adult, Purple, Disp pkg, LF
• 00634782544225: BP Kit,Adult, Black, DM PL
• 00843515000192: PROSPHYG Aneroid Sphyg, Dlx Cs,Adult, Tokidoki, KOI PL, LF
• 00843515000185: PROSPHYG Aneroid Sphyg, Dlx Cs,Adult, Camouflage, KOI PL, LF
• 00843515000178: PROSPHYG Aneroid Sphyg,Adult, Tokidoki, KOI PL, LF
• 00843515000161: PROSPHYG Aneroid Sphyg,Adult, Pink Cheetah, KOI PL,LF
• 00843515000154: PROSPHYG Aneroid Sphyg,Adult, Leopard, KOI PL, LF
• 00843515234450: PROSPHYG Aneroid Sphyg,Adult, Camouflage, KOI PL, LF
• 00634782599812: Standard Aneroid Sphyg,3 cuff, Navy, LF
• 00634782602581: Prosphyg Aneroid Sphyg,Adult, Power Pink, Disp, LF
• 00634782602574: Prosphyg Aneroid Sphyg,Adult, Watercolors, Disp, LF