Critical Cover

Basic Information

• Brand Name: Critical Cover
• Primary DI: 10817583021950
• Version / Model: CV-14032-8
• Catalog Number: CV-14032-8
• Company Name: ALPHA PRO TECH INC
• Labeler DUNS: 003687733
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2020-12-21
• Public Version: 2
• Public Version Date: 2021-04-07
• Public Version Status: Update
• Public Device Record Key: fb58634e-cb03-4734-9358-ff28eac9001a

Device Description

Coverall, GenPro, White, Inset Sleeve, Zip Close, Tapered Collar, Elastic Wrist, Ankle & Back, 5XL

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
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	878.4040	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58390	Visitor hygiene coverall	A garment intended to be worn by a visitor, or staff, in a healthcare facility as temporary clean clothing when with patients in non-sterile environments that may require a higher level of hygiene than a normal patient ward [e.g., intensive care unit (ICU), postoperative recovery ward]. Also known as a jump suit, it is a one-piece suit (overall) with sleeves, trouser legs, and fasteners intended to be worn over existing clothing to provide a barrier to help prevent cross-contamination of infectious agents between visitor and patients. This is a single-use garment.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20817583021957	GS1	Case	1	In Commercial Distribution
Primary	10817583021950	GS1
Unit of Use	00817583021953	GS1

Customer Contacts

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