INSTRUMENT TRANSPORT BAG

Basic Information

• Brand Name: INSTRUMENT TRANSPORT BAG
• Primary DI: 00843356102413
• Version / Model: ITB1218-H
• Company Name: CYGNUS MEDICAL L.L.C.
• Labeler DUNS: 103169095
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2021-10-31
• Public Version: 2
• Public Version Date: 2022-05-12
• Public Version Status: Update
• Public Device Record Key: a931f14a-f0fd-4b06-b3e3-a682f109aa41

Device Description

INSTRUMENT TRANSPORT BAG 12'' x 18'', 2MIL RESEALABLE COMPOSTABLE BAG PRINTED W/ HIGH LEVEL DISINFECTED LABEL - 100 TRANSPORT BAGS PER CARRIER

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEJ	Carrier, Ligature	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64018	Instrument hygienic-transportation bag	A non-sterile flexible plastic container intended to collect and contain an instrument(s) [e.g., an endoscope] following an invasive procedure, for hygienic transportation of the device to a reprocessing facility. It is typically a drawstring bag/wrap which may be designed to be laid flat on the procedure tray/trolley during the procedure and then closed to contain the device; it is not a drape/cover. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00843356102413	GS1
Package	10843356102410	GS1		2	In Commercial Distribution
Unit of Use	30843356102414	GS1