Medline

Basic Information

• Brand Name: Medline
• Primary DI: 10080196291700
• Version / Model: MDS200500IR
• Catalog Number: MDS200500IR
• Company Name: MEDLINE INDUSTRIES, INC.
• Labeler DUNS: 025460908
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-14
• Public Version: 3
• Public Version Date: 2023-09-29
• Public Version Status: Update
• Public Device Record Key: 591285b3-0300-4142-a716-b5d17e1a9106

Device Description

PACK,TEST,INSTANT READ,BIOLOGICAL STEAM

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRC	Indicator, biological sterilization process	General Hospital	880.2800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47825	Surgical instrument track identification tape	A non-sterile, colour-coded, band coated on one side with a pressure-sensitive adhesive intended to attach to a surgical instrument; it is typically wrapped around the handle or shaft to indicate instrument ownership (e.g., by doctor, hospital floor, department or ward) and identifies the instrument prior to and during a surgical procedure. This marking will facilitate that the correct instruments are returned to the correct owner particularly after being sterilized in the hospital sterilization department or other facility. It is typically made of plastic material and is available in a sheet with different size strips of tape or in continuous roll (a spool). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10080196291700	GS1
Package	40080196291701	GS1	CASE	30	In Commercial Distribution

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Do not store near sterilants or other chemical
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry
• Type: Storage Environment Humidity
• Temperature Range: 10 – 70 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 10 – 38 Degrees Celsius