ProtectX LTF-0218-25

GUDID 20860005250039

AAMI LEVEL 3 DISPOSABLE PROTECTIVE GOWN OVER THE HEAD WITH THUMB LOOP NONSTERILE EXTRA LARGE YELLOW

The Azac Group

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• Primary Device ID: 20860005250039
• NIH Device Record Key: ee7202d0-7d4c-4ace-acc9-687706f90781
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProtectX
• Version Model Number: LTF-0218-25
• Catalog Number: LTF-0218-25
• Company DUNS: 067056009
• Company Name: The Azac Group
• Device Count: 10
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	10860005250032 [Unit of Use]
GS1	20860005250039 [Primary]
GS1	30860005250036 [Package]; Package: Plastic Bag [2 Units]; In Commercial Distribution
GS1	40860005250033 [Package]; Package: Box [8 Units]; In Commercial Distribution
GS1	50860005250030 [Package]; Package: Case [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211538

FDA Product Code

• QPC: Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-15
• Device Publish Date: 2022-04-07

On-Brand Devices [ProtectX]

• 20860005250060: AAMI LEVEL 3 DISPOSABLE PROTECTIVE GOWN OVER THE HEAD WITH THUMB LOOP NONSTERILE EXTRA LARGE BL
• 20860005250039: AAMI LEVEL 3 DISPOSABLE PROTECTIVE GOWN OVER THE HEAD WITH THUMB LOOP NONSTERILE EXTRA LARGE YEL