Getinge Assured Green Tape 24mm (Steam)

Basic Information

• Brand Name: Getinge Assured Green Tape 24mm (Steam)
• Primary DI: 00814434020455
• Version / Model: 6001154903
• Catalog Number: 6001154903
• Company Name: STERITEC PRODUCT MFG. CO., INC.
• Labeler DUNS: 622223196
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 4
• Public Version Date: 2018-09-26
• Public Version Status: Update
• Public Device Record Key: 3b3dcde0-0ff0-47e6-b67b-e8c67575854b
• Distribution End Date: 2018-09-25

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: 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	880.2800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44427	Sterilization packaging tape	A non-sterile, flexible, band (typically made of paper) coated on one side with a pressure-sensitive adhesive, used to seal packages of instruments, utensils, or medical devices that are wrapped in drapes or sterilization packaging, prior to being sterilized in the hospital or other facility. This device will typically have indicators on its non-adhesive side that darken to indicate that the package has been sterilized. It typically comes in rolls in a variety of widths. After application, this device cannot be reused.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10814434020452	GS1	Case	36	Not in Commercial Distribution	2018-09-25
Primary	00814434020455	GS1

Premarket Submissions

Submission Number	Supplement Number
K122555	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 38 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 60 Percent (%) Relative Humidity