VALULINE 5251-532

GUDID 10366975012989

MASK VALULINE LEVEL 3 BLU BX50

BENCO DENTAL SUPPLY CO.

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

• Primary Device ID: 10366975012989
• NIH Device Record Key: 0f9c8f98-31a9-4a02-80fb-692a5f3c02a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VALULINE
• Version Model Number: 5251-532
• Catalog Number: 5251-532
• Company DUNS: 015108087
• Company Name: BENCO DENTAL SUPPLY CO.
• Device Count: 50
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place. Avoid excessive heat (40°C or 104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place. Avoid excessive heat (40°C or 104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place. Avoid excessive heat (40°C or 104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place. Avoid excessive heat (40°C or 104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place. Avoid excessive heat (40°C or 104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place. Avoid excessive heat (40°C or 104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place. Avoid excessive heat (40°C or 104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place. Avoid excessive heat (40°C or 104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place. Avoid excessive heat (40°C or 104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place. Avoid excessive heat (40°C or 104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place. Avoid excessive heat (40°C or 104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place. Avoid excessive heat (40°C or 104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place. Avoid excessive heat (40°C or 104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place. Avoid excessive heat (40°C or 104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place. Avoid excessive heat (40°C or 104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place. Avoid excessive heat (40°C or 104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place. Avoid excessive heat (40°C or 104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place. Avoid excessive heat (40°C or 104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place. Avoid excessive heat (40°C or 104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place. Avoid excessive heat (40°C or 104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place. Avoid excessive heat (40°C or 104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place. Avoid excessive heat (40°C or 104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place. Avoid excessive heat (40°C or 104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place. Avoid excessive heat (40°C or 104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place. Avoid excessive heat (40°C or 104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place. Avoid excessive heat (40°C or 104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place. Avoid excessive heat (40°C or 104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place. Avoid excessive heat (40°C or 104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place. Avoid excessive heat (40°C or 104°F)
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool dry place. Avoid excessive heat (40°C or 104°F)

Device Identifiers

Device Issuing Agency	Device ID
GS1	00366975012982 [Primary]
GS1	00366975013125 [Unit of Use]
GS1	10366975012989 [Package]; Contains: 00366975012982; Package: CASE [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051291

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: 2018-01-31

On-Brand Devices [VALULINE]

• 10366975012989: MASK VALULINE LEVEL 3 BLU BX50
• 10366975012972: MASK VALULINE LEVEL 3 PNK BX50
• 00366975010056: VALULINE VPS MONO FS REFILL
• 00366975010070: VALULINE VPS MONO FS INTRO KT
• 00366975010049: VALULINE VPS HB FS REFILL
• 00366975010063: VALULINE VPS HB FS INTRO KT
• 10366975003031: POUCH VALULINE 2.25X4 BX200
• 10366975003024: POUCH VALULINE 2.75X9 BX200
• 10366975003017: POUCH VALULINE 5.25X10 BX200
• 10366975003000: POUCH VALULINE 3.5X9 BX500
• 00366975002990: POUCH VALULINE 3.5X9 BX200
• 10366975002980: POUCH VALULINE 3.5X5.25 BX200
• 10366975035889: 5519-271
• 00366975060266: 5749-326
• 00366975060259: 5749-317
• 00366975060242: 5749-308
• 00366975060235: 5749-282
• 00366975060228: 5749-273
• 00366975057570: 5447-821
• 00366975057563: 5447-812
• 00366975035882: 5519-262
• 00366975035165: 5495-547
• 00366975035158: 5495-538
• 00366975035141: 5495-529
• 00366975035134: 5495-510
• 00366975010377: 5220-726
• 00366975010353: 5220-708
• 00366975010339: 5220-824
• 00366975010322: 5220-815
• 00366975010315: 5220-806
• 00366975010308: 5220-799
• 00366975010292: 5220-780
• 00366975010285: 5220-771
• 00366975010278: 5220-762
• 00366975010261: 5220-753
• 00366975010254: 5220-744
• 00366975010247: 5220-735