Critical Cover 695MED

GUDID 20817583020141

N95 NIOSH APPROVED, DOUBLE HEADBAND, POSITIVE FACIAL LOCK.

ALPHA PRO TECH INC

Surgical/medical respirator, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use

• Primary Device ID: 20817583020141
• NIH Device Record Key: 2ce6c14e-e263-4a48-920d-d8510fba64dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Critical Cover
• Version Model Number: 695MED
• Catalog Number: 695MED
• Company DUNS: 003687733
• Company Name: ALPHA PRO TECH INC
• Device Count: 35
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 801-355-5816
• Email: XX@XX.XX
• Phone: 801-355-5816
• Email: XX@XX.XX
• Phone: 801-355-5816
• Email: XX@XX.XX
• Phone: 801-355-5816
• Email: XX@XX.XX
• Phone: 801-355-5816
• Email: XX@XX.XX
• Phone: 801-355-5816
• Email: XX@XX.XX
• Phone: 801-355-5816
• Email: XX@XX.XX
• Phone: 801-355-5816
• Email: XX@XX.XX
• Phone: 801-355-5816
• Email: XX@XX.XX
• Phone: 801-355-5816
• Email: XX@XX.XX
• Phone: 801-355-5816
• Email: XX@XX.XX
• Phone: 801-355-5816
• Email: XX@XX.XX
• Phone: 801-355-5816
• Email: XX@XX.XX
• Phone: 801-355-5816
• Email: XX@XX.XX
• Phone: 801-355-5816
• Email: XX@XX.XX
• Phone: 801-355-5816
• Email: XX@XX.XX
• Phone: 801-355-5816
• Email: XX@XX.XX
• Phone: 801-355-5816
• Email: XX@XX.XX

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817583020147 [Unit of Use]
GS1	10817583020144 [Primary]
GS1	20817583020141 [Package]; Contains: 10817583020144; Package: CASE [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092824

FDA Product Code

• MSH: Respirator,Surgical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-05-06
• Device Publish Date: 2016-11-03

On-Brand Devices [Critical Cover]

• 20817583021100: Shoe Cover, SureGrip, Anti-Skid, Serged Seams, Blue, XL.
• 20817583021087: Shoe Cover, SureGrip, Anti-Skid, Serged Seams, Blue, Universal
• 20817583020967: Shoe Cover, MaxGrip, BarrierTech Upper, Anti-Skid Sole, Serged Seams, White, Large.
• 10817583020649: POSITIVE FACIAL LOCK ,EARLOOPS, BLUE
• 10817583020632: POSITIVE FACIAL LOCK , HEADBAND, BLUE
• 20817583020691: Sleeve, ComforTech, Sterile, Sonic Welded Seams, White, Universal.
• 20817583020684: Sleeve, ComforTech, Sterile, Sonic Welded Seams, White, XL
• 20817583020615: EARLOOP, WHITE
• 20817583020592: EARLOOP, BLUE
• 20817583020585: TIE STRING MASK, BLUE
• 10817583020571: TIE STRING MASK, BLUE
• 20817583020561: TIE STRING MASK, BLUE
• 20817583020332: TIE STRING MASK, BLUE
• 20817583020325: EARLOOP, YELLOW
• 20817583020318: EARLOOP, PINK
• 20817583020301: EARLOOP, GREEN
• 20817583020295: EARLOOP, BLUE
• 20817583020288: EARLOOP, WHITE
• 20817583020271: EARLOOP, WHITE
• 20817583020264: EARLOOP, BLUE
• 20817583020257: EARLOOP, YELLOW
• 20817583020240: EARLOOP, PINK
• 10817583020236: EARLOOP, GREEN
• 20817583020226: PLEATED MASK w/ EARLOOP, BLUE
• 20817583020219: TIE STRING MASK, BLUE
• 20817583020202: EARLOOP, BLUE
• 2081758302189: POSITIVE FACIAL LOCK, EARLOOP, WHITE
• 10817583020175: TIE STRING MASK ,WHITE
• 20817583020165: EARLOOP, WHITE
• 20817583020158: EARLOOP, WHITE
• 10817583020007: POSITVE FACIAL LOCK, HEADBAND, BLUE
• 20817583020622: POSITIVE FACIAL LOCK, HEADBAND, BLUE
• 20817583020141: N95 NIOSH APPROVED, DOUBLE HEADBAND, POSITIVE FACIAL LOCK.
• 20817583020134: N95 NIOSH APPROVED, DOUBLE HEADBAND, POSITIVE FACIAL LOCK.
• 20817583020127: N95 NIOSH APPROVED, DOUBLE HEADBAND, POSITIVE FACIAL LOCK.
• 20817583020110: LASER MASK, HEADBAND, GREY STRIPE.
• 20817583020103: POSITIVE FACIAL LOCK, HEADBAND, BLUE
• 20817583020097: POSITIVE FACIAL LOCK,HEADBAND, WHITE
• 20817583020080: POSITIVE FACIAL LOCK EARLOOP PINK STRIPE.
• 20817583020073: POSITIVE FACIAL LOCK, EARLOOP, PURPLE DESIGN
• 20817583020066: POSITIVE FACIAL LOCK, EARLOOP, BLUE STRIPE.
• 20817583020059: POSITIVE FACIAL LOCK, EARLOOP, BLUE
• 20817583020042: POSITIVE FACIAL LOCK, EARLOOP, BLUE
• 20817583020035: POSITIVE FACIAL LOCK,HEADBAND,PURPLE DESIGN
• 20817583020028: POSITIVE FACIAL LOCK, HEADBAND, BLUE STRIPE
• 30817583020018: POSITIVE FACIAL LOCK, HEADBAND, BLUE
• 20817583023357: Lab Coat, AlphaGuard, Blue, Tapered Collar, Knit Wrist, Zip Close, 3 Pockets, 3XL
• 20817583023340: Lab Coat, AlphaGuard, Blue, Tapered Collar, Knit Wrist, Zip Close, 3 Pockets, XL
• 20817583023326: Face Veil, White, with Comfort Band, 12"X15"
• 20817583023319: Full Face Shield, anti-fog, foam strip, attached comfort headband with snaps