Spectrum, Inc.

Basic Information

• Brand Name: Spectrum, Inc.
• Primary DI: 00850301007822
• Version / Model: 987-03879-000
• Catalog Number: 725400
• Company Name: SPECTRUM, INC.
• Labeler DUNS: 080458964
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-07-21
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: ec28cf20-b69f-408c-9438-297b013051c3

Device Description

LDPE Specimine Containers, 32 & 64 Oz, 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: Yes
• 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: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LPZ	Container, frozen donor tissue storage	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
47776	General specimen container IVD, no additive, sterile	A sterile covered plastic receptacle containing no additives intended to be used for the collection, and preservation and/or transport, of any type of diagnostic specimen (e.g., urine, faeces, sputum, mucous, tissue) for analysis and/or other investigation. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850301007829	GS1	Shipper	10	In Commercial Distribution
Primary	00850301007822	GS1

Customer Contacts

• Phone: [phone] ext. 3
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K863872	000