| Primary Device ID | M783SF1195701 |
| NIH Device Record Key | 2128c0c5-93c6-44a5-8146-bb529a4be2e1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Diversatek Healthcare |
| Version Model Number | SF-1195-70 |
| Catalog Number | SF-1195-70 |
| Company DUNS | 030650113 |
| Company Name | DIVERSATEK HEALTHCARE, 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 800-558-6408 |
| sales@diversatekhc.com | |
| Phone | 800-558-6408 |
| sales@diversatekhc.com | |
| Phone | 800-558-6408 |
| sales@diversatekhc.com | |
| Phone | 800-558-6408 |
| sales@diversatekhc.com | |
| Phone | 800-558-6408 |
| sales@diversatekhc.com | |
| Phone | 800-558-6408 |
| sales@diversatekhc.com | |
| Phone | 800-558-6408 |
| sales@diversatekhc.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M783SF1195700 [Primary] |
| HIBCC | M783SF1195701 [Package] Contains: M783SF1195700 Package: Case [500 Units] In Commercial Distribution |
| HIF | Insufflator, Laparoscopic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[M783SF1195701]
Ethylene Oxide
[M783SF1195701]
Ethylene Oxide
[M783SF1195701]
Ethylene Oxide
[M783SF1195701]
Ethylene Oxide
[M783SF1195701]
Ethylene Oxide
[M783SF1195701]
Ethylene Oxide
[M783SF1195701]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-12-11 |
| Device Publish Date | 2019-12-03 |
| 00816734022726 | Non-Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Gastric and Esophageal) |
| M7831201891 | Basic Endoscopy Procedure Kit |
| M7831201491 | Endoscopy Basic Procedure Kit |
| M783SF1195701 | Insufflation Filter |
| M7831201481 | Basic Endoscopy Procedure Kit |
| M7831201941 | Basic Endoscopy Procedure Kit |
| M7831201961 | Basic Endoscopy Procedure Kit |
| M78312011001 | Basic Endoscopy Procedure Kit |
| 00816734023341 | ZepHr Pack |
| 00816734022412 | Non-Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal) |
| 00816734022405 | Non-Infused Single-Use Z/pH Probe (External Reference), Single pH (Esophageal) |
| 00816734022399 | Non-Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal) |
| 00816734022382 | Non-Infused Single-Use Z/pH Probe (External Reference), Dual pH (Gastric & Esophageal) |
| 00816734022375 | Non-Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Gastric and Esophageal) |
| 00816734022368 | Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal) with LES Locator, Loc |
| 00816734022351 | Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Gastric and Esophageal), Locator Po |
| 00816734022344 | Non-Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal) |
| 00816734022337 | Non-Infused Single-Use Z/pH Probe (External Reference), Single pH (Esophageal) |
| 00816734022320 | Non-Infused Single-Use Z/pH Probe (Internal Reference), Triple Sensor |
| 00816734022313 | Single-Use Z/pH Probe (External Reference), Single pH (Esophageal) |
| 00816734022306 | Non-Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal) |
| 00816734022290 | Single-Use Z/pH Probe (External Reference), Dual pH (Gastric & Esophageal) |
| 00816734022283 | Non-Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Gastric & Esophageal) |
| 00816734022276 | Non-Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Esophageal) |
| 00816734022269 | Single-Use Z/pH Probe (External Reference), Single pH (Esophageal) with LES Locator, Locator Por |
| 00816734022252 | Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal) with LES Locator, Loc |
| 00816734022245 | LPR Probe, Dual pH (Esophageal), LPR Acid, Locator Port 6cm |
| 00816734022238 | LPR Probe, Dual pH (Esophageal), LPR Acid, Locator Port 6cm |
| 00816734022221 | LPR Probe, Dual pH (Esophageal), LPR Acid, Locator Port 6cm |
| 00816734022214 | Single-Use Z/pH Probe (External Reference), Dual pH (Gastric and Esophageal), Locator Port 6cm |
| 00816734022207 | Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Gastric and Esophageal), Locator Po |
| 00816734022191 | Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Esophageal) with LES Locator, Locat |
| 00816734022115 | Bioview® Manometry Acquisition Software |
| 00816734022108 | Single-Use pH Probe, Non-Infused, Single pH (Esophageal) |
| 00816734022092 | Single-Use pH Probe, Non-Infused, Single pH (Esophageal) |
| 00816734022085 | Single-Use pH Probe, Non-Infused, Dual pH (Esophageal) with LES Port |
| 00816734022078 | Single-Use pH Probe, Non-Infused, Dual pH (Esophageal) 21cm Spacing |
| 00816734022061 | Single-Use pH Probe, Non-Infused, Dual pH (Esophageal) 15cm Spacing |
| 00816734022054 | Single-Use pH Probe, Non-Infused, Dual pH (Esophageal) 10cm Spacing |
| 00816734022047 | Single-Use pH Probe, Non-Infused, Dual pH (Esophageal) 10cm Spacing |
| 00816734022030 | Single-Use pH Probe, Infused, Single pH (Esophageal) with LES Port |
| 00816734022023 | Single-Use pH Probe, Infused, Dual pH (Esophageal) 5cm Spacing with LES Port |
| 00816734022016 | Single-Use pH Probe, Infused, Dual pH (Esophageal) 15cm Spacing with LES Port |
| 00816734022009 | Single-Use pH Probe, Infused, Dual pH (Esophageal) 10cm Spacing with LES Port |
| 00816734021934 | EFT Viscous Solution |
| 00816734021927 | Buffer Solution, pH 7.0 +/- 0.05 @ 25C, 250ml |
| 00816734021910 | Buffer Solution, pH 4.0 +/- 0.05 @ 25C, 250ml |
| 00816734021903 | Buffer Solution, pH 1.0 +/- 0.05 @ 25C, 250ml |
| 00816734021897 | Buffer Solution, pH 7.0 +/- 0.05 @ 25C, 500ml |
| 00816734021880 | Buffer Solution, pH 4.0 +/- 0.05 @ 25C, 500ml |