PremierPro 2497

GUDID 00811220033712

PremierPro MRI Safe Earloop Masks, 50 per box

SVS LLC

Surgical/medical face mask, single-use

• Primary Device ID: 00811220033712
• NIH Device Record Key: 96b84307-aa9a-4341-b6fb-d7990b636862
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PremierPro
• Version Model Number: 2497
• Catalog Number: 2497
• Company DUNS: 831375089
• Company Name: SVS LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811220033712 [Package]; Contains: 00811220033729; Package: case [6 Units]; In Commercial Distribution
GS1	00811220033729 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123787

FDA Product Code

• FXX: Mask, Surgical

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: 2022-02-21
• Device Publish Date: 2022-02-11

On-Brand Devices [PremierPro]

• 10818566017366: Earloop Procedure Mask, ASTM Level 2, Green
• 00818566017031: Central Line Kit - Tegaderm 1655 Oval with Medipore, Biopatch CHG disc, 3M CVC Securement, 4x4 G
• 00818566017024: Central Line Kit - Tegaderm 1616, Biopatch CHG disc, STATLOCK PICC PLUS, 4x4 Gauze, ChloraPrep 3
• 00818566017017: Central Line Kit - Tegaderm CHG Dressing, 4x4 Gauze, ChloraPrep 3m w/Insert, 3M Swabstick, Tripl
• 00818566017000: Central Line Kit - Tegaderm 1688, Biopatch CHG disc, 4x4 Gauze, ChloraPrep 3m w/Insert, 3M Swabs
• 00818566016997: Central Line Kit - Tegaderm 1655, Biopatch CHG disc, 4x4 Gauze, ChloraPrep 3m w/Insert, 3M Swabs
• 00818566016980: Central Line Kit - Tegaderm 1616, Biopatch CHG disc, 4x4 Gauze, ChloraPrep 3m w/Insert, 3M Swabs
• 00818566016973: Central Line Kit - Tegaderm 1626, 4x4 Gauze, Chloraprep 3ml w/Insert, 3M Swabstick, Triple Swabs
• 00818566016966: Central Line Kit - Tegaderm 1616, 4x4 Gauze, Chloraprep 3ml w/Insert, 3M Swabstick, Triple Swabs
• 10818566016611: OR Towels Non-Sterile, 100 Bulk, White, 400/cs
• 10818566016604: OR Towels Non-Sterile, 100 Bulk, Green, 400/cs
• 10818566016598: OR Towels Non-Sterile, 100 Bulk, Blue, 400/cs
• 10818566016581: Surgical Tie Mask, Soft, Anti-Fog Foam, ASTM 1, White
• 10818566016574: Surgical Tie Mask, Anti-Fog Film, ASTM 1, Green
• 10818566016567: Surgical Tie Mask, Anti-Fog Foam, ASTM 3, Sea Blue
• 10818566016550: Surgical Tie Mask, Anti-Fog Foam, ASTM 1, Denim Blue
• 10818566016543: Surgical Tie Mask, Soft, Large Soft Bill, ASTM 3, White
• 10818566016536: Surgical Tie Mask, Horizontal Ties, ASTM 1, Gray
• 10818566016529: Surgical Tie Mask, Soft, ASTM 1, White
• 10818566016512: Surgical Tie Mask, Large Soft Bill, ASTM 1, Green
• 10818566016505: Surgical Tie Mask, Soft Bill, ASTM 1, Light Blue
• 10818566016499: Surgical Tie Mask, ASTM 1, Light Blue
• 10818566016482: Surgical Tie Mask, Anti-Fog Foam & Visor, ASTM 3, Sea Blue
• 10818566016475: Surgical Tie Mask, Anti-Fog Foam & Visor, Anti-Glare, ASTM 3, Sea Blue
• 10818566016468: Surgical Tie Mask, Anti-Fog Tape, ASTM 1, Green
• 10818566016451: Earloop Procedure Mask, Anti-Fog Foam & Visor, ASTM 3, Sea Blue
• 10818566016444: Earloop Procedure Mask, Anti-Fog Foam, ASTM 3, Sea Blue
• 10818566016437: Seracult Plus Fecal Occult Blood Test, Developer
• 10818566016420: Seracult Plus Fecal Occult Blood Test, Single Slide
• 10818566016413: Seracult Fecal Occult Blood Test, Developer
• 10818566016406: Seracult Fecal Occult Blood Test, Triple Slide
• 10818566016390: Seracult Fecal Occult Blood Test, Tape and Developer Kit
• 10818566016383: Seracult Fecal Occult Blood Test, Single Slide
• 10818566016376: Seracult Plus Fecal Occult Blood Test, Triple Slide Mailing Kit
• 10818566016369: Seracult Plus Fecal Occult Blood Test, Single Slide
• 10818566016352: Seracult Fecal Occult Blood Test, Triple Slide Mailing Kit
• 10818566016345: Seracult Fecal Occult Blood Test, Triple Slide Patient Kit
• 10818566016338: Seracult Fecal Occult Blood Test, Single Slide
• 10818566016147: Digital Thermometer, Flexible Oral
• 10818566016130: Digital Thermometer, Rectal
• 10818566016123: Digital Thermometer, Oral
• 10818566013658: Ultrasound Gel, Low Viscosity, 250 mL, Non-Sterile
• 20818566013358: Digital Thermometer, Oral, Individually Boxed
• 10818566013344: Digital Thermometer, Flexible Oral, Bulk
• 10818566013337: Digital Thermometer, Rectal, Bulk
• 10818566013320: Digital Thermometer, Oral, Bulk
• 10818566013306: Earloop Procedure Mask, Pink
• 00818566013262: Sphygmomanometer, Adult, Pink
• 10818566013061: Manual Resuscitation Bag, Adult
• 10818566013054: Manual Resuscitation Bag, Child