DOLPHIN II

Basic Information

• Brand Name: DOLPHIN II
• Primary DI: 00821925030930
• Version / Model: DOL-TUB
• Company Name: Gyrus Acmi, Inc.
• Labeler DUNS: 007198742
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-13
• Public Version: 5
• Public Version Date: 2023-09-29
• Public Version Status: Update
• Public Device Record Key: c0c3ac89-c0a0-4eeb-a81d-5968dfcb3153

Device Description

Dolphin II Transducer Tubing

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HIG	INSUFFLATOR, HYSTEROSCOPIC	Obstetrics/Gynecology	884.1700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12144	Hysteroscopic insufflator	A mains electricity (AC-powered) device assembly used during endoscopic procedures of the uterus (i.e., hysteroscopy) to distend (expand by pressure) the uterus by filling the uterine cavity with a pressure-limited gas [typically carbon dioxide (CO2)] providing the operator with a space in which to carry out an examination or surgical intervention. Electronics assist in monitoring the pressure and maintaining the gas-filled space by compensating for gas leakage. 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
Package	00821925001770	GS1		5	In Commercial Distribution
Primary	00821925030930	GS1

Premarket Submissions

Submission Number	Supplement Number
K011876	000