HIGHFLOW

Basic Information

• Brand Name: HIGHFLOW
• Primary DI: 04055207056585
• Version / Model: 2235601
• Catalog Number: 2235601
• Company Name: Richard Wolf GmbH
• Labeler DUNS: 315304071
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-07-21
• Public Version: 5
• Public Version Date: 2023-11-23
• Public Version Status: Update
• Public Device Record Key: 97e9bfad-c576-4fb0-bc3a-a3f4c36fdeb4

Device Description

INSUFFLATOR 45 BASIC FR 45L/MIN the base version, US version, compatible with core nova, touch screen, color display, U: 100-240VAC, 50/60Hz, Dim. (wxhxd): 300x160x455mm

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HIF	INSUFFLATOR, LAPAROSCOPIC	Obstetrics/Gynecology	884.1730	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16849	Laparoscopic insufflator	A mains electricity (AC-powered) device designed to distend the peritoneal cavity by filling it with a pressure-limited gas [typically carbon dioxide (CO2)] providing the operator with a space (pneumoperitoneum) in which to perform an examination or surgical intervention. Electronics assist in monitoring the pressure and maintaining the gas-filled space by compensating for gas leakage. Other surgical instruments may be introduced into the peritoneal cavity through other laparoscopic ports. This device may also be referred to as a gas distention system.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04055207056585	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]