MEDICOM SAFEBASICS

Basic Information

• Brand Name: MEDICOM SAFEBASICS
• Primary DI: 20686864049641
• Version / Model: 8034-W
• Catalog Number: 8034-W
• Company Name: AMD Medicom Inc
• Labeler DUNS: 256880576
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1000
• Record Status: Published
• Publish Date: 2019-01-13
• Public Version: 3
• Public Version Date: 2023-06-16
• Public Version Status: Update
• Public Device Record Key: daf0ca04-ae00-47e0-aa8b-e324d692ede0
• Distribution End Date: 2023-06-15

Device Description

MEDICOM SAFEBASICS BOUFFANT CAP 24 Inch

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
FYF	CAP, SURGICAL	General, Plastic Surgery	878.4040	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32297	Surgical cap, single-use	A head covering designed as a cap intended to be worn by surgical staff during an operation to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material; it may also be used as a hygienic head covering in other healthcare settings. It is usually made of reinforced paper or non-woven materials. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20686864049641	GS1
Unit of Use	00686864049647	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			24 Inch

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Cool dry place