| Primary Device ID | 00634782595975 |
| NIH Device Record Key | 5dd38524-ce51-421b-90f5-d32aea44dd48 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Prosphyg™ |
| Version Model Number | 768-609-11ARB |
| Catalog Number | 768-609-11ARB |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 1-800-232-2670 |
| info@adctoday.com | |
| Phone | 1-800-232-2670 |
| info@adctoday.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00634782094591 [Primary] |
| GS1 | 00634782595975 [Package] Contains: 00634782094591 Package: Master Case [10 Units] In Commercial Distribution |
| DXQ | Blood Pressure Cuff |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-08 |
| Device Publish Date | 2018-09-07 |
| 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 |