Spectrum, Inc.

Basic Information

• Brand Name: Spectrum, Inc.
• Primary DI: 00850301007587
• Version / Model: DG2M-230
• Catalog Number: DG2M-110-50S
• Company Name: SPECTRUM, INC.
• Labeler DUNS: 039727656
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-30
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: ea0943a6-62f0-4fe0-be09-11cbb3348b54

Device Description

Hydrophilic Syringe Tip Filter - DG2M-110-50S, Sterile

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: MR Safe
• 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: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FPB	Filter, infusion line	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46817	Syringe filter, clinical	A sterile membrane intended to be used in a syringe or connected to a syringe (e.g., between the syringe and the needle or cannula) to sterilize, ultraclean, or clarify medicinal solutions during pharmaceutical preparation or patient injection. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00850301007594	GS1	Shipper	50	In Commercial Distribution
Primary	00850301007587	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K852996	000