Crosstex International GCABL

GUDID D682GCABL2D

Advantage earloop mask/BLUE

CROSSTEX INTERNATIONAL, INC.

Surgical/medical respirator, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use

• Primary Device ID: D682GCABL2D
• NIH Device Record Key: f3b454f3-f891-463b-bde9-668e8898e49d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Crosstex International
• Version Model Number: GCABL
• Catalog Number: GCABL
• Company DUNS: 057728685
• Company Name: CROSSTEX INTERNATIONAL, INC.
• Device Count: 50
• DM Exempt: true
• 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: true
• 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

Customer Support Contacts

• Phone: +1(888)276-7783
• Email: crosstex@crosstex.com
• Phone: +1(888)276-7783
• Email: crosstex@crosstex.com
• Phone: +1(888)276-7783
• Email: crosstex@crosstex.com
• Phone: +1(888)276-7783
• Email: crosstex@crosstex.com
• Phone: +1(888)276-7783
• Email: crosstex@crosstex.com
• Phone: +1(888)276-7783
• Email: crosstex@crosstex.com
• Phone: +1(888)276-7783
• Email: crosstex@crosstex.com
• Phone: +1(888)276-7783
• Email: crosstex@crosstex.com
• Phone: +1(888)276-7783
• Email: crosstex@crosstex.com
• Phone: +1(888)276-7783
• Email: crosstex@crosstex.com
• Phone: +1(888)276-7783
• Email: crosstex@crosstex.com
• Phone: +1(888)276-7783
• Email: crosstex@crosstex.com
• Phone: +1(888)276-7783
• Email: crosstex@crosstex.com
• Phone: +1(888)276-7783
• Email: crosstex@crosstex.com
• Phone: +1(888)276-7783
• Email: crosstex@crosstex.com
• Phone: +1(888)276-7783
• Email: crosstex@crosstex.com
• Phone: +1(888)276-7783
• Email: crosstex@crosstex.com
• Phone: +1(888)276-7783
• Email: crosstex@crosstex.com
• Phone: 1-585-359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: 1-585-359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: 1-585-359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: 1-585-359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: 1-585-359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: 1-585-359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: 1-585-359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: 1-585-359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: 1-585-359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: 1-585-359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: 1-585-359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: 1-585-359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: 1-585-359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: 1-585-359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: 1-585-359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: 1-585-359-0130
• Email: regulatoryaffairs@hu-friedy.com
• Phone: 1-585-359-0130
• Email: regulatoryaffairs@hu-friedy.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00732224120515 [Unit of Use]
GS1	10732224120512 [Primary]
HIBCC	D682GCABL2D [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133070

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: 4
• Public Version Date: 2020-05-06
• Device Publish Date: 2017-02-11

On-Brand Devices [Crosstex International]

• D682GPRN9525: Isolator Plus N95 Mask
• 50732224004162: Lead-Free Blue Indicator Steam Tape, 0.71 in X 60 yd (18 mm X 55 m) Roll
• 50732224004155: Lead-Free Blue Steam Indicator Tape, 0.94 in X 60 yd (24 mm X 55 m) Roll
• 50732224004148: Lead-Free Steam Indicator Tape, 0.47 in X 60 yd (12 mm X 55 m) Roll
• 50732224004131: Lead-Free Steam Indicator Tape, 0.71 in X 60 yd (18 mm X 55 m) Roll
• 50732224004124: Lead-Free Steam Indicator Tape, 0.94 in X 60 yd (24 mm X 55 m) Roll
• 50732224110481: (XTEX ADVANTAGE 2.75X9)
• 50732224110474: (POUCH 2.75X9 SELFSEAL)
• 50732224110467: (XTEX 5.25x6.5 SURE CHECK)
• 50732224110450: (XTEX 2.75X9 SURE CHECK)
• 50732224110092: (CROSSTEX 2x8 POUCH)
• 50732224110085: (XTEX 2.25X4 SURE CHECK)
• 50732224110078: (XTEX 2.25X4 STERIL POUCH)
• 50732224110023: (XTEX ADVANTAGE 3.5X5.25)
• 50732224110009: (XTEX 3.5X5.25 INTRNL IND)
• 50732224109997: (POUCH 3.5X5.25 SELFSEAL)
• 50732224109898: (SANI-ROLL 6"-200 M,2/CS)
• 50732224109881: (SANI-ROLL 6- 100' ROLLS)
• 50732224109867: (SANI-ROLL 4"-200 M,4/CS)
• 50732224109850: (SANI-ROLL 4- 100' ROLLS)
• 50732224109836: (SANI-ROLL 3"-200 M,4/CS)
• 50732224109829: (SANI-ROLL 3- 100' ROLLS)
• 50732224109805: (SANI-ROLL 2"-200 M,8/CS)
• 50732224109799: (SANI-ROLL 2- 100' ROLLS)
• 10732224109784: (SANI-ROLL 12"-200 M,1/CS)
• 50732224109737: (PINK PUR POUCH 3.5X9)
• 50732224109706: (CROSSTEX 3.5X9 PCH,500/BX)
• 50732224109690: (XTEX ADVANTAGE 3.5X9)
• 50732224109676: (3.5X9 SURE.CHECK-500/BX)
• 50732224109669: (SURE-CHECK 3.50" x 9", 200/BX - 20/CS)
• 50732224109621: (POUCH 3.5X9 SELFSEAL)
• 50732224109614: (CROSSTEX 3.25X9 SELFSEAL)
• 50732224109560: (PINK PUR POUCH 5.25X10)
• 50732224109522: (XTEX ADVANTAGE 5.25X10)
• 50732224109515: (SURE-CHECK 5.25" x 10", 200/BX - 10/CS)
• 50732224109454: (XTEX 8 X 16 SC POUCH)
• 50732224109447: (CROSSTEX POUCH 8X16)
• 50732224109423: (XTEX 5.25x15 SURE CK PCH)
• 50732224109416: Crosstex Pouch 5.25X15
• 50732224109409: Crosstex 3.5X22 Sure Check
• 50732224109393: Crosstex Pouch 3.5X22
• 50732224109386: (SURE-CHECK 7.50" x 13", 200/BX - 5/CS)
• 50732224109362: Sure-Check 12" x 18", 100/BX - 5/CS
• 50732224109355: Pouch 12X18 Self Seal
• 50732224109331: (XTEX 12 X 15 SURE CHECK)
• 50732224109324: (POUCH 12X15/SELF-SEAL)
• 50732224109317: (CROSSTEX 10.5X17 SURE CHECK)
• 50732224109294: (SURE CHECK 10X15 POUCH)
• 50732224109287: (POUCH 10X15 SELF SEAL)
• 50732224109270: (POUCH 7.5X13 SELFSEAL)