Fisherbrand

Basic Information

• Brand Name: Fisherbrand
• Primary DI: 00613647005958
• Version / Model: 02 544 208
• Catalog Number: 02544208
• Company Name: FISHER SCIENTIFIC COMPANY L.L.C.
• Labeler DUNS: 004321519
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 60
• Record Status: Published
• Publish Date: 2022-12-07
• Public Version: 1
• Public Version Date: 2022-12-15
• Public Version Status: New
• Public Device Record Key: c7f7923e-7fce-46ba-9079-2790d0fb7ff4

Device Description

SPECIMEN COLLECTION SYST 60/CS

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KDT	CONTAINER, SPECIMEN MAILER AND STORAGE, STERILE	Pathology	864.3250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65197	Rectal/faecal specimen collection kit	A collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of a rectal/faecal specimen for subsequent laboratory analysis [e.g., nucleic acid technique (NAT), microbiological culture]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, spatula], and a covered receptacle with or without an additive/medium (e.g., cell or nucleic acid preservation solution, Carey-Blair transport medium). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20613647005952	GS1	CASE	1	In Commercial Distribution
Primary	00613647005958	GS1
Unit of Use	10613647005955	GS1

Customer Contacts

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