Rospital Productos Medicos AMP318

GUDID 10812460027780

FOLEY CATHETER, 3 WAY 18FR, 30 ML, EA. SILICONE COATED.

ATLAS MEDICAL PRODUCTS LLC

Indwelling urethral drainage balloon catheter, non-antimicrobial

• Primary Device ID: 10812460027780
• NIH Device Record Key: 5b5b563a-42d0-4f1f-973b-9cf077c27fdf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rospital Productos Medicos
• Version Model Number: AMP318
• Catalog Number: AMP318
• Company DUNS: 013112308
• Company Name: ATLAS MEDICAL PRODUCTS 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 786-473-9436
• Email: levalenzuela17@gmail.com
• Phone: 786-473-9436
• Email: levalenzuela17@gmail.com
• Phone: 786-473-9436
• Email: levalenzuela17@gmail.com
• Phone: 786-473-9436
• Email: levalenzuela17@gmail.com
• Phone: 786-473-9436
• Email: levalenzuela17@gmail.com
• Phone: 786-473-9436
• Email: levalenzuela17@gmail.com
• Phone: 786-473-9436
• Email: levalenzuela17@gmail.com
• Phone: 786-473-9436
• Email: levalenzuela17@gmail.com
• Phone: 786-473-9436
• Email: levalenzuela17@gmail.com
• Phone: 786-473-9436
• Email: levalenzuela17@gmail.com
• Phone: 786-473-9436
• Email: levalenzuela17@gmail.com
• Phone: 786-473-9436
• Email: levalenzuela17@gmail.com
• Phone: 786-473-9436
• Email: levalenzuela17@gmail.com
• Phone: 786-473-9436
• Email: levalenzuela17@gmail.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812460027783 [Primary]
GS1	10812460027780 [Package]; Contains: 00812460027783; Package: INNER [10 Units]; In Commercial Distribution
GS1	20812460027787 [Package]; Package: CASE [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082815

FDA Product Code

• EZL: Catheter, Retention Type, Balloon

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-12-04
• Device Publish Date: 2020-06-13

On-Brand Devices [Rospital Productos Medicos]

• 10812460026684: LATEX POLYMER POWDER FREE SURGICAL GLOVES (PALM TEXTURE) SIZE 6.5, PAIR
• 10812460026677: LATEX POLYMER POWDER FREE SURGICAL GLOVES (PALM TEXTURE) SIZE 6, PAIR
• 10812460026660: LATEX POLYMER POWDER FREE SURGICAL GLOVES (PALM TEXTURE) SIZE 8, PAIR
• 10812460026653: LATEX POLYMER POWDER FREE SURGICAL GLOVES (PALM TEXTURE) SIZE 7.5, PAIR
• 10812460026646: LATEX POLYMER POWDER FREE SURGICAL GLOVES (PALM TEXTURE), SIZE 7, Pair
• 10812460027421: HYPODERMIC, NEEDLES, STERILE, BLISTER, LUER LOCK 22 G x 1 1/2" EA.
• 10812460027414: HYPODERMIC, NEEDLES, STERILE, BLISTER, LUER LOCK 21 G x 1 1/2", EA.
• 10812460027407: HYPODERMIC, NEEDLES, STERILE, BLISTER, LUER LOCK 21 G x 1", EA.
• 10812460027384: HYPODERMIC NEEDLES, STERILE, BLISTER, LUER LOCK, 30G X 1/2 ", EA.
• 10812460027377: HYPODERMIC NEEDLES, STERILE, BLISTER, LUER LOCK, 27G X 1 1/2", EA.
• 10812460027360: HYPODERMIC NEEDLES, STERILE, BLISTER, LUER LOCK, 23G X 1 1/2 ", EA.
• 10812460028114: SURGEON'S GOWN, MEDIUM, KNITTED CUFF WITH 2 PIECE HAND TOWEL & WRAP - 1 EA/POUCH
• 10812460028107: SURGEON'S GOWN, LARGE, KNITTED CUFF WITH 2 PIECE HAND TOWEL & WRAP - 1 EA/POUCH.
• 10812460028091: SURGEON'S GOWN, EXTRA LARGE, KNITTED CUFF WITH 2 PIECE HAND TOWEL & WRAP - 1 EA/POUCH
• 10812460027667: FEEDING TUBES 8FR, X-RAY, EA.
• 10812460027650: FEEDING TUBES 6FR, X-RAY, EA.
• 10812460027643: FEEDING TUBES 5FR, X-RAY, EA.
• 10812460027193: HYPODERMIC SAFETY NEEDLE WITH 10CC SYRINGE LUER LOCK 22G X 1 1/2",EA.
• 00812460027189: HYPODERMIC SAFETY NEEDLE WITH 10CC SYRINGE LUER LOCK 21G X 1 1/2",EA.
• 10812460027179: HYPODERMIC SAFETY NEEDLE WITH 5CC SYRINGE LUER LOCK 21 X 1 1/2",EA.
• 10812460027162: HYPODERMIC SAFETY NEEDLE WITH 5CC SYRINGE LUER LOCK 21 X 1.EA.
• 00812460027158: HYPODERMIC SAFETY NEEDLE WITH 3CC SYRINGE LUER LOCK 23G x 1 1/2, EA,
• 10812460027148: HYPODERMIC SAFETY NEEDLE WITH 3CC SYRINGE LUER LOCK 23G x 1, EA,
• 10812460027131: HYPODERMIC SAFETY NEEDLE WITH 3CC SYRINGE LUER LOCK 22G x 1 1/2, EA
• 10812460027124: HYPODERMIC SAFETY NEEDLE WITH 3CC SYRINGE LUER LOCK 21G X 1 1/2, EA.
• 10812460026882: 1ML TUBERCULIN SYRINGE WITH DETACHABLE NEEDLE LUER LOCK 27G X 1/2 IN EACH,
• 10812460026875: 1ML TUBERCULIN SYRINGE WITH DETACHABLE NEEDLE LUER LOCK 25G X 5/8 IN, EACH
• 10812460028428: CLOSED WOUND DRAINAGE SYSTEM 19 FR, EA.
• 10812460028381: FLAT SILICONE DRAIN KIT 100 ML, PERFORATION EA.
• 10812460028374: URINE BAG, 2000ML, ANTI-REFLUX VALVE, EA.
• 10812460028367: SPECIMEN CONTAINER, STERILE, 4 OZ. EA.
• 10812460028350: SPECIMEN CONTAINER, NONSTERILE, 4 OZ EA.
• 10812460028176: NASAL OXYGEN CANNULA, PEDIATRIC.EA.
• 10812460028169: NASAL OXYGEN CANNULA, ADULT. EA
• 10812460028152: OXYGEN MASK W/TUBING, CHILD. EA.
• 10812460028145: OXYGEN MASK W/TUBING, ADULT. EA.
• 10812460028138: FACE MASK EARLOOP 3 PLY EA.
• 20812460028128: ISOLATION GOWN. EA.
• 10812460028084: SURGEONS CAP: NON-WOVEN WITH TIE, BLUE, EA.
• 10812460028015: ORTHOPAEDIC CAST PADDING 100% COTTON - 3"X4 YARDS, EA.
• 10812460028008: ORTHOPAEDIC CAST PADDING 100% COTTON - 4"X4 YARDS, EA.
• 10812460027995: ORTHOPAEDIC CAST PADDING 100% COTTON - 6"X4 YARDS, EA,
• 10812460027896: NON-SAFETY (REGULAR) BLOOD COLLECTION SET 23G X 3/4", Each
• 10812460026776: INSULINE SYRINGE 0.5CC 30G X 1/2" EACH,
• 10812460026752: INSULINE SYRINGE 1 ML 32G X 5/16" EACH
• 10812460026738: 1ML INSULIN SYRINGE-U-100 WITH PERMANENTLY ATTACHED NEEDLE 31G X 5/16 IN. Each
• 10812460026707: 1ML INSULIN SYRINGE-U-100 WITH PERMANENTLY ATTACHED NEEDLE 30G X 1/2 IN., Each
• 30812460028255: SHOE COVERS 17 X 41CM, STANDARD, EA. 100/BOX
• 30812460028248: SHOE COVERS 17 X 41 CM, NON-SKID, EA. 100/BOX
• 30812460028231: NURSE'S CAP, WHITE. EA. 100/BX.