Moldex

GUDID 00092311151304

MOLDEX-METRIC, INC.

Surgical/medical respirator, single-use

• Primary Device ID: 00092311151304
• NIH Device Record Key: ae6d869f-f126-4ba0-a5eb-1e4559cd4698
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Moldex
• Version Model Number: 1513 N95
• Company DUNS: 066237736
• Company Name: MOLDEX-METRIC, INC.
• Device Count: 20
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00092311151304 [Primary]
GS1	10092311151301 [Unit of Use]
GS1	50092311151309 [Package]; Package: [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061859

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: 2016-09-16

On-Brand Devices [Moldex]

• 50092311221767: 2217GN95-LP
• 50092311221262: 2212GN95-M/L
• 50092311221163: 2211GN95-S
• 00092311221007: 2210GN95-XS
• 50092311171208: 1712 N95
• 5092311151705: 1517 N95
• 00092311151304: 1513 N95
• 50092311151200: 1512 N95
• 50092311151101: 1511 N95
• 00092311151007: 1510 N95