Diversatek Healthcare SF-1195-70

GUDID M783SF1195701

Insufflation Filter

DIVERSATEK HEALTHCARE, INC.

Endoscopic insufflation tubing set, single-use

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

Customer Support Contacts

Phone	800-558-6408
Email	sales@diversatekhc.com
Phone	800-558-6408
Email	sales@diversatekhc.com
Phone	800-558-6408
Email	sales@diversatekhc.com
Phone	800-558-6408
Email	sales@diversatekhc.com
Phone	800-558-6408
Email	sales@diversatekhc.com
Phone	800-558-6408
Email	sales@diversatekhc.com
Phone	800-558-6408
Email	sales@diversatekhc.com
Phone	800-558-6408
Email	sales@diversatekhc.com
Phone	800-558-6408
Email	sales@diversatekhc.com
Phone	800-558-6408
Email	sales@diversatekhc.com
Phone	800-558-6408
Email	sales@diversatekhc.com
Phone	800-558-6408
Email	sales@diversatekhc.com
Phone	800-558-6408
Email	sales@diversatekhc.com
Phone	800-558-6408
Email	sales@diversatekhc.com
Phone	800-558-6408
Email	sales@diversatekhc.com
Phone	800-558-6408
Email	sales@diversatekhc.com
Phone	800-558-6408
Email	sales@diversatekhc.com
Phone	800-558-6408
Email	sales@diversatekhc.com
Phone	800-558-6408
Email	sales@diversatekhc.com
Phone	800-558-6408
Email	sales@diversatekhc.com
Phone	800-558-6408
Email	sales@diversatekhc.com
Phone	800-558-6408
Email	sales@diversatekhc.com
Phone	800-558-6408
Email	sales@diversatekhc.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M783SF1195700 [Primary]
HIBCC	M783SF1195701 [Package] Contains: M783SF1195700 Package: Case [500 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K922038

FDA Product Code

HIF	Insufflator, Laparoscopic

Sterilization

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

[M783SF1195701]

Ethylene Oxide

[M783SF1195701]

Ethylene Oxide

[M783SF1195701]

Ethylene Oxide

[M783SF1195701]

Ethylene Oxide

[M783SF1195701]

Ethylene Oxide

[M783SF1195701]

Ethylene Oxide

[M783SF1195701]

Ethylene Oxide

[M783SF1195701]

Ethylene Oxide

[M783SF1195701]

Ethylene Oxide

[M783SF1195701]

Ethylene Oxide

[M783SF1195701]

Ethylene Oxide

[M783SF1195701]

Ethylene Oxide

[M783SF1195701]

Ethylene Oxide

[M783SF1195701]

Ethylene Oxide

[M783SF1195701]

Ethylene Oxide

[M783SF1195701]

Ethylene Oxide

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2019-12-11
Device Publish Date	2019-12-03

On-Brand Devices [Diversatek Healthcare]

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