Metro-Pacifica

GUDID 00609626000021

Face mask with regular earloops - White

Metro Medical Supply

Surgical/medical face mask, single-use Surgical/medical face mask, single-use Surgical/medical face mask, single-use

• Primary Device ID: 00609626000021
• NIH Device Record Key: 8a149554-3255-4a0e-a2e5-2d383fa3c899
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Metro-Pacifica
• Version Model Number: ELM-970
• Company DUNS: 080604969
• Company Name: Metro Medical Supply
• Device Count: 1000
• 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

Customer Support Contacts

• Phone: (615) 312-9800
• Email: customerservice@metromedical.com
• Phone: (615) 312-9800
• Email: customerservice@metromedical.com
• Phone: (615) 312-9800
• Email: customerservice@metromedical.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight and keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight and keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight and keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00609626000014 [Unit of Use]
GS1	00609626000021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K911334

FDA Product Code

• FXX: Mask, 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: 3
• Public Version Date: 2020-05-06
• Device Publish Date: 2018-09-20

On-Brand Devices [Metro-Pacifica]

• 00609626062661: Face mask with regular earloops + shield - White
• 00609626062647: Face mask with regular earloops + shield - White
• 00609626062630: Face mask with long earloops - White
• 00609626000038: Face mask with long earloops - White
• 00609626000021: Face mask with regular earloops - White
• 00609626000007: Face mask with regular earloops - White
• 00609626063545: NitriSense Ultra 25; Patient Examination Gloves; Powder Free Nitrile; XL
• 00609626063514: NitriSense Ultra 25; Patient Examination Gloves; Powder Free Nitrile; Large
• 00609626063484: NitriSense Ultra 25; Patient Examination Gloves; Powder Free Nitrile; Medium
• 00609626063453: NitriSense Ultra 25; Patient Examination Gloves; Powder Free Nitrile; Small
• 00609626063422: NitriSense Ultra 25; Patient Examination Gloves; Powder Free Nitrile; XS
• 00609626063392: NitriSense Ultra; Patient Examination Gloves; Powder Free Nitrile; XL
• 00609626063361: NitriSense Ultra; Patient Examination Gloves; Powder Free Nitrile; Large
• 00609626063330: NitriSense Ultra; Patient Examination Gloves; Powder Free Nitrile; Medium
• 00609626063309: NitriSense Ultra; Patient Examination Gloves; Powder Free Nitrile; Small
• 00609626063279: NitriSense Ultra; Patient Examination Gloves; Powder Free Nitrile; XS
• 00609626063248: NitriSoft II; Patient Examination Gloves; Powder Free Nitrile; XXL
• 00609626063217: NitriSoft II; Patient Examination Gloves; Powder Free Nitrile; XL
• 00609626063187: NitriSoft II; Patient Examination Gloves; Powder Free Nitrile; Large
• 00609626063156: NitriSoft II; Patient Examination Gloves; Powder Free Nitrile; Medium
• 00609626063125: NitriSoft II; Patient Examination Gloves; Powder Free Nitrile; Small
• 00609626063095: NitriSoft II; Patient Examination Gloves; Powder Free Nitrile; XS
• 00609626062944: Clinikleen; Powder Free Latex Exam Gloves; XL
• 00609626062913: Clinikleen; Powder Free Latex Exam Gloves; Large
• 00609626062883: Clinikleen; Powder Free Latex Exam Gloves; Medium
• 00609626062852: Clinikleen; Powder Free Latex Exam Gloves; Small
• 00609626062821: Clinikleen; Powder Free Latex Exam Gloves; XS
• 00609626062791: Control Plus; Tactilex; Patient Examination Gloves; Powder Free Latex; XL
• 00609626062760: Control Plus; Tactilex; Patient Examination Gloves; Powder Free Latex; Large
• 00609626062739: Control Plus; Tactilex; Patient Examination Gloves; Powder Free Latex; M
• 00609626062708: Control Plus; Tactilex; Patient Examination Gloves; Powder Free Latex; S
• 00609626062678: Control Plus; Tactilex; Patient Examination Gloves; Powder Free Latex; XS
• 00609626064054: Patient Examination Gloves Powder-Free Vinyl XS
• 00609626000151: Patient Examination Gloves Powder-Free Vinyl XL
• 00609626000120: Patient Examination Gloves Powder-Free Vinyl L
• 00609626000090: Patient Examination Gloves Powder-Free Vinyl M
• 00609626000069: Patient Examination Gloves Powder-Free Vinyl S
• 00609626064023: Patient Examination Gloves Powder Free Nitrile XL
• 00609626063996: Patient Examination Gloves Powder Free Nitrile L
• 00609626063965: Patient Examination Gloves Powder Free Nitrile M
• 00609626063934: Patient Examination Gloves Powder Free Nitrile S
• 00609626063903: Patient Examination Gloves Powder Free Nitrile XS
• 00609626063873: Ultra Patient Examination Gloves Powder Free Nitrile XL
• 00609626063842: Ultra Patient Examination Gloves Powder Free Nitrile L
• 00609626063811: Ultra Patient Examination Gloves Powder Free Nitrile M
• 00609626063781: Ultra Patient Examination Gloves Powder Free Nitrile S
• 00609626063750: Ultra Patient Examination Gloves Powder Free Nitrile XS
• 00609626063729: Patient Examination Gloves Powder-Free Nitrile XXL
• 00609626063699: Patient Examination Gloves Powder-Free Nitrile XL
• 00609626063668: Patient Examination Gloves Powder-Free Nitrile L