Unomedical, Mouth to Mask Resuscitator with Filter Adult Mask 1058MM

GUDID 00084424900061

Unomedical, Mouth to Mask Resuscitator with Filter Adult Mask

CONVATEC, PURCHASING DEPARTMENT

Resuscitator face mask, single-use

• Primary Device ID: 00084424900061
• NIH Device Record Key: bd6310f6-2b23-415e-bd72-cdf0e60cc05e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unomedical, Mouth to Mask Resuscitator with Filter Adult Mask
• Version Model Number: 1058MM
• Catalog Number: 1058MM
• Company DUNS: 809784593
• Company Name: CONVATEC, PURCHASING DEPARTMENT
• Device Count: 1
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00084424900061 [Primary]
GS1	10844249000622 [Package]; Package: carton [10 Units]; In Commercial Distribution
GS1	20844249000629 [Package]; Contains: 10844249000622; Package: case [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K873286

FDA Product Code

• BTM: Ventilator, Emergency, Manual (Resuscitator)

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: 2019-10-01
• Device Publish Date: 2015-10-15

Devices Manufactured by CONVATEC, PURCHASING DEPARTMENT

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