ASP MEDICAL

GUDID 10840216108995

MASK, LV2 FACE, W/VISOR, TIES, BLUE, ANTI-FOG FOAM

ASP GLOBAL, LLC

Surgical/medical face mask, single-use

• Primary Device ID: 10840216108995
• NIH Device Record Key: b13a5e5a-96b6-4f0c-b989-f5babc830424
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASP MEDICAL
• Version Model Number: FMT645V
• Company DUNS: 080361159
• Company Name: ASP GLOBAL, LLC
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840216108998 [Primary]
GS1	10840216108995 [Package]; Contains: 00840216108998; Package: INNER BOX [25 Units]; In Commercial Distribution
GS1	20840216108992 [Package]; Package: CASE [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182515

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: 2020-10-29
• Device Publish Date: 2020-10-21

On-Brand Devices [ASP MEDICAL]

• 00840216107960: MASK, SURGICAL, BLUE, EARLOOP 3-PLY, LEVEL 2, 50EA/BX, 40BX/CS (2000EA/CS)
• 10840216101637: CONTACT LENS CASE SCREW TOP
• 10840216109039: MASK, FACE, BLUE, EARLOOPS, ANTI-FOG FOAM, TESTED TO ASTM F1862 (FLUID PROTECTION BARRIER) LEVEL
• 10840216109022: MASK, FACE, W/VISOR, TIES, BLUE, ANTI-FOG FOAM, TESTED TO ASTM F1862 (FLUID PROTECTION BARRIER)
• 10840216109015: MASK, LV2 FACE, W/VISOR, EARLOOPS, BLUE, ANTI-FOG FOAM
• 10840216108995: MASK, LV2 FACE, W/VISOR, TIES, BLUE, ANTI-FOG FOAM
• 10840216108971: FMT655
• 10840216108964: MASK, LV2 FACE, ANTI-FOG, W/TIES, BLUE
• 10840216108940: MASK, LV2 FACE, ANTI-FOG, EARLOOPS, BLUE
• 10840216108735: MASK, FACE, W/ EXTENDED SHIELD, BLUE, EARLOOPS, TESTED TO ASTM F1862 (FLUID PROTECTION BARRIER)
• 20840216108640: MASK, FACE, BLUE, EARLOOPS, TESTED TO ASTM F1862 (FLUID PROTECTION BARRIER) LEVEL 3
• 10840216101750: OR TOWEL, STERILE, BLUE, 100% COTTON, 16"X25", 55GSM, 2EA/PK 40PK/CS
• 10840216101668: SPECIMEN TRAP 40CC, W/ TRANSPORT CAP, STERILE
• 10840216108742: DRAPE, TRANSPARENT INTUBATION, 56"X70", AAMI LEVEL 2, 1" ADHESIVE CENTERED ON LONG SIDE OF DRAPE
• 10840216110929: MASK, LVL 2 FACE, BLUE W/HEARTS, EARLOOPS, 3-PLY, ASTM 1862, 50EA/BX, 40BX/CS (2000EA/CS)
• 10840216107639: DIGITAL THERMOMETER, 25 SECOND, ORAL, 20EA/BX, 20BX/CS (400EA/CS)
• 00840216104211: PAD, CPM COOL QUILT, W/STRAPS 3 1/2" X 29 W/VELCRO, POLYESTER, 1EA/BG, 6BG/CS
• 00840216117594: BINDER, ABDOMINAL, 12" LG/XL (46"-62"), 4 PANEL, WHITE
• 00840216117587: BINDER, ABDOMINAL, 12" 2XL (62"-75"), 4 PANEL, WHITE
• 00840216117570: BINDER, ABDOMINAL, 9" 2XL (62"-75"), 3 PANEL, WHITE
• 00840216117563: BINDER, ABDOMINAL, 12" S/M (30"-45"), 4 PANEL, WHITE
• 00840216117556: BINDER, ABDOMINAL, 9" LG/XL (46"-62"), 3 PANEL, WHITE
• 00840216117549: BINDER, ABDOMINAL, 9" S/M (30"-45"), 3 PANEL, WHITE
• 00840216104334: REUSABLE PILLOW - WHITE, 1/EA
• 00840216106208: CUSTOM ZIP LOCK BIO-HAZARD BAG W/ HANDLES, 1/EA,250/CS
• 00840216117891: BAG, DRUG TRANSPORT, YELLOW, 16"X19", 100EA/PK, 5PK/CS (500EA/CS)
• 00840216106215: BAG TRANSPORT DRUG 12X15, SINGLE POCKET 4.0 MIL 1/EA, 50/BG, 500/CS (10BG/CS)
• 00840216101036: CONE FACE MASK, WHITE, 1/EA
• 00840216118386: MASK, FACE BASIC, PLASTIC NOSE STRIP, BLUE, EARLOOPS, 3-PLY, LATEX FREE, 50EA/BX, 40BX/CS (2000E
• 00840216118379: MASK, FACE BASIC, NO NOSE STRIP/PIECE, BLUE, EARLOOPS, 3-PLY, LATEX FREE, 50EA/BX, 40BX/CS (2000
• 00840216118263: GOWN, ISOLATION YELLOW, XLARGE, SMMS, OVER THE HEAD, FULL BACK, TIE WAIST, THUMBHOOK W/ELASTIC W
• 00840216118256: GOWN, ISOLATION YELLOW, UNIVERSAL, SMMS, OVER THE HEAD, FULL BACK, TIE WAIST, THUMBHOOK W/ELASTI
• 00840216111271: MASK, TRANSPARENT FACE, EARLOOPS, ANTI-FOG, 24EA/BX, 18BX/CS (432EA/CS)
• 00840216111219: GOWN, ISOLATION AAMI LEVEL 2, OVER THE HEAD, 4XLARGE, YELLOW, FULL BACK, TIE WAIST, THUMBHOOK W/
• 00840216111202: GOWN, ISOLATION AAMI LEVEL 2, OVER THE HEAD, 3XLARGE, YELLOW, FULL BACK, TIE WAIST, THUMBHOOK W/
• 00840216110915: GOWN, BLUE PROCEDURE, UNIVERSAL, POLYCOATED, OVER THE HEAD, THUMBHOOKS, BACK TIE WAIST, 10EA/BG,
• 00840216110496: GOWN, YELLOW ISOLATION SBPP, KNIT CUFFS, 10EA/BG, 10BG/CS (100EA/CS)
• 00840216108295: MASK, CHILDRENS FACE, BLUE, EARLOOP, 3 PLY, LATEX FREE, 50EA/BX, 6BX/CS (300EA/CS)
• 00840216107939: MASK, BLUE, EARLOOP, 3 PLY #1, 50EA/BX, 40BX/CS (2000EA/CS)
• 00840216107588: GOWN, ISOLATION AAMI LEVEL 2, UNIVERSAL, YELLOW, FULL BACK COVERAGE, T
• 00840216106871: GOWN, ISOLATION AAMI LEVEL 2, OVER THE HEAD, 2XLARGE, YELLOW, FULL BACK, PERFORATED NECK, TIE WA
• 00840216106864: GOWN, ISOLATION AAMI LEVEL 2, OVER THE HEAD, XLARGE, YELLOW, FULL BACK, PERFORATED NECK, TIE WAI
• 00840216106857: GOWN, ISOLATION AAMI LEVEL 2, OVER THE HEAD, UNIVERSAL, YELLOW, FULL BACK, PERFORATED NECK, TIE
• 00840216106444: GOWN, ISOLATION LEVEL 2, UNIVERSAL, YELLOW, OVER THE HEAD, OPEN BACK, TIE WAIST, THUMBLOOP, 3-LA
• 00840216106437: GOWN, ISOLATION LEVEL 2, UNIVERSAL, YELLOW, FULL BACK, TAPE-NECK CLOSURE, TIE WAIST, ELASTIC CUF
• 00840216102484: ISOLATION GOWN YELLOW, LARGE, 1/EA,10/BG,50/CS
• 00840216103702: SPECIMENCONTAINER,120ML 4OZ ,SCREW-ONLIDS,NON-STERILE, 1/EA,500/CS
• 00840216103689: GRADUATED URINE CUP, 1100 ML
• 00840216103672: SPECIMEN COLLECTOR PAN, 800CC, 1/EA,100/CS
• 00840216103665: GRADUATED URINE CUP, 300 ML