KIT,SAMPLE,AGENTS,3160

Basic Information

• Brand Name: KIT,SAMPLE,AGENTS,3160
• Primary DI: 00884838107304
• Version / Model: Kit, Sample, Agents, 3160
• Catalog Number: 94018
• Company Name: Philips Ds North America LLC
• Labeler DUNS: 013649151
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-30
• Public Version: 3
• Public Version Date: 2024-02-01
• Public Version Status: Update
• Public Device Record Key: b4ad0392-0d06-4191-a9fc-3cfb965dc874

Device Description

KIT,SAMPLE,AGENTS,3160

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MWI	Monitor, physiological, patient (without arrhythmia detection or alarms)	Cardiovascular	870.2300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33513	Exhaled-gas sample collector, non-electronic	A container intended to collect a sample of a patient's exhaled gas for subsequent analysis. The container may be flexible or rigid and may have a soft disposable liner in which the sample is collected. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884838107304	GS1

Customer Contacts

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