Philips Healthcare

Basic Information

• Brand Name: Philips Healthcare
• Primary DI: 07613327664096
• Version / Model: 85900P
• Catalog Number: 85900P
• Company Name: STRYKER SUSTAINABILITY SOLUTIONS, INC.
• Labeler DUNS: 020198912
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-11
• Public Version: 1
• Public Version Date: 2025-02-19
• Public Version Status: New
• Public Device Record Key: 8ac9dab4-1634-4f57-9c24-065ec5322a87

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: Yes
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
OBJ	Catheter, ultrasound, intravascular	Cardiovascular	870.1200	2
OWQ	Reprocessed intravascular ultrasound catheter	Cardiovascular	870.1200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64174	Intravascular ultrasound imaging catheter, reprocessed	A flexible, non-steerable tube with an ultrasound imaging transducer enclosed in a fluid-resistant or waterproof acoustically- and electrically-insulated housing, designed for insertion into the vascular system (i.e., peripheral vascular system, coronary artery) by an operator; it is not intended for intracardial insertion/imaging. Also known as a vascular ultrasound transducer, it includes a single or an array of transducer element(s). This is a previously used single-use device that has been processed for an additional single-use patient application.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	57613327664091	GS1	case	10	In Commercial Distribution
Primary	07613327664096	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K223026	000