Diversatek Healthcare 1201-49

GUDID M7831201491

Endoscopy Basic Procedure Kit

DIVERSATEK HEALTHCARE, INC.

Endoscopy preparation kit
Primary Device IDM7831201491
NIH Device Record Keyb2e7d529-6fce-4665-921d-9cce1a77bc3a
Commercial Distribution StatusIn Commercial Distribution
Brand NameDiversatek Healthcare
Version Model Number1201-49
Catalog Number1201-49
Company DUNS030650113
Company NameDIVERSATEK HEALTHCARE, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-558-6408
Emailsales@diversatekhc.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM7831201490 [Primary]
HIBCCM7831201491 [Package]
Contains: M7831201490
Package: Box [20 Units]
In Commercial Distribution

FDA Product Code

FCHTray, Biopsy, Without Biopsy Instruments

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-10-23
Device Publish Date2019-08-14

On-Brand Devices [Diversatek Healthcare]

00816734022726Non-Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Gastric and Esophageal)
M7831201891Basic Endoscopy Procedure Kit
M7831201491Endoscopy Basic Procedure Kit
M783SF1195701Insufflation Filter
M7831201481Basic Endoscopy Procedure Kit
M7831201941Basic Endoscopy Procedure Kit
M7831201961Basic Endoscopy Procedure Kit
M78312011001Basic Endoscopy Procedure Kit
00816734023341ZepHr Pack
00816734022412Non-Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal)
00816734022405Non-Infused Single-Use Z/pH Probe (External Reference), Single pH (Esophageal)
00816734022399Non-Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal)
00816734022382Non-Infused Single-Use Z/pH Probe (External Reference), Dual pH (Gastric & Esophageal)
00816734022375Non-Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Gastric and Esophageal)
00816734022368Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal) with LES Locator, Loc
00816734022351Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Gastric and Esophageal), Locator Po
00816734022344Non-Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal)
00816734022337Non-Infused Single-Use Z/pH Probe (External Reference), Single pH (Esophageal)
00816734022320Non-Infused Single-Use Z/pH Probe (Internal Reference), Triple Sensor
00816734022313Single-Use Z/pH Probe (External Reference), Single pH (Esophageal)
00816734022306Non-Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal)
00816734022290Single-Use Z/pH Probe (External Reference), Dual pH (Gastric & Esophageal)
00816734022283Non-Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Gastric & Esophageal)
00816734022276Non-Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Esophageal)
00816734022269Single-Use Z/pH Probe (External Reference), Single pH (Esophageal) with LES Locator, Locator Por
00816734022252Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal) with LES Locator, Loc
00816734022245LPR Probe, Dual pH (Esophageal), LPR Acid, Locator Port 6cm
00816734022238LPR Probe, Dual pH (Esophageal), LPR Acid, Locator Port 6cm
00816734022221LPR Probe, Dual pH (Esophageal), LPR Acid, Locator Port 6cm
00816734022214Single-Use Z/pH Probe (External Reference), Dual pH (Gastric and Esophageal), Locator Port 6cm
00816734022207Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Gastric and Esophageal), Locator Po
00816734022191Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Esophageal) with LES Locator, Locat
00816734022115Bioview® Manometry Acquisition Software
00816734022108Single-Use pH Probe, Non-Infused, Single pH (Esophageal)
00816734022092Single-Use pH Probe, Non-Infused, Single pH (Esophageal)
00816734022085Single-Use pH Probe, Non-Infused, Dual pH (Esophageal) with LES Port
00816734022078Single-Use pH Probe, Non-Infused, Dual pH (Esophageal) 21cm Spacing
00816734022061Single-Use pH Probe, Non-Infused, Dual pH (Esophageal) 15cm Spacing
00816734022054Single-Use pH Probe, Non-Infused, Dual pH (Esophageal) 10cm Spacing
00816734022047Single-Use pH Probe, Non-Infused, Dual pH (Esophageal) 10cm Spacing
00816734022030Single-Use pH Probe, Infused, Single pH (Esophageal) with LES Port
00816734022023Single-Use pH Probe, Infused, Dual pH (Esophageal) 5cm Spacing with LES Port
00816734022016Single-Use pH Probe, Infused, Dual pH (Esophageal) 15cm Spacing with LES Port
00816734022009Single-Use pH Probe, Infused, Dual pH (Esophageal) 10cm Spacing with LES Port
00816734021934EFT Viscous Solution
00816734021927Buffer Solution, pH 7.0 +/- 0.05 @ 25C, 250ml
00816734021910Buffer Solution, pH 4.0 +/- 0.05 @ 25C, 250ml
00816734021903Buffer Solution, pH 1.0 +/- 0.05 @ 25C, 250ml
00816734021897Buffer Solution, pH 7.0 +/- 0.05 @ 25C, 500ml
00816734021880Buffer Solution, pH 4.0 +/- 0.05 @ 25C, 500ml

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