Medline

Basic Information

• Brand Name: Medline
• Primary DI: 00080196322957
• Version / Model: DYNJE1001
• Catalog Number: DYNJE1001
• Company Name: MEDLINE INDUSTRIES, INC.
• Labeler DUNS: 025460908
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-20
• Public Version: 1
• Public Version Date: 2021-01-28
• Public Version Status: New
• Public Device Record Key: 7299bce3-2633-4291-a8b3-7085cc841087

Device Description

BAG,SPONGE COUNTER,BLUE,50/BX,5BX/CS

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: 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
LWH	Counter, sponge, surgical	General Hospital	880.2740	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64548	Surgical sponge-counting bag	A device in the form of a bag intended to be used in the operating room (OR) to store and maintain the count of surgical sponges/swabs during a surgical procedure to prevent these items from being inadvertently left in a patient. It is a bag with individual pockets/sections and is typically hung on an associated rack (not included); it may be weighed following sponge/swab collection to calculate blood loss. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	40080196322955	GS1	CASE	250	In Commercial Distribution
Package	30080196322958	GS1	BOX	50	In Commercial Distribution
Primary	00080196322957	GS1

Customer Contacts

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