AMD-RITMED

Basic Information

• Brand Name: AMD-RITMED
• Primary DI: 10686864969928
• Version / Model: AHM0044
• Catalog Number: AHM0044
• Company Name: AMD Medicom Inc
• Labeler DUNS: 256880576
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-15
• Public Version: 7
• Public Version Date: 2020-06-19
• Public Version Status: Update
• Public Device Record Key: 06c25d45-129a-46d4-880b-4cf2987dd2a4
• Distribution End Date: 2018-03-06

Device Description

HEMOSTAT GAUZE 4" X 4" STERILE

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: 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRO	Dressing, wound, drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
58059	Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial	A non-bioabsorbable device derived from plant polysaccharides [e.g., micro-dispersed oxidized cellulose (M-Doc), oxidized regenerated cellulose (ORC), calcium alginate] intended for topical application to a traumatic wound (e.g., abrasion, laceration, cut), ulcer, and/or surgical wound, to facilitate local haemostasis; it does not contain an antimicrobial agent. It is available in various forms (e.g., gel, spray, powder, ointment, plaster/gauze pad, fibre/wool) that can be applied directly to the wound where it forms a seal until removed. The device is intended for use in the home or healthcare facility. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20686864969925	GS1	OUTER CASE	80	Not in Commercial Distribution	2018-03-06
Package	10686864979934	GS1	INNER BOX	10	Not in Commercial Distribution	2018-03-06
Primary	10686864969928	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone] ext. 2309
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			4 x 4 Inch

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Between 5°C and 40°C (i.e. 41°F and 104°F)