Rospital Productos Medicos CCA04

GUDID 10812460027704

FOLEY CATHETER, 2 WAY 18FR, 10 ML,EA. 100% SILICONE .

ATLAS MEDICAL PRODUCTS LLC

Indwelling urethral drainage balloon catheter, non-antimicrobial

Primary Device ID	10812460027704
NIH Device Record Key	1d607915-d1f0-48e2-aac9-fd5c39f90c46
Commercial Distribution Status	In Commercial Distribution
Brand Name	Rospital Productos Medicos
Version Model Number	CCA04
Catalog Number	CCA04
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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00812460027707 [Primary]
GS1	10812460027704 [Package] Contains: 00812460027707 Package: INNER [10 Units] In Commercial Distribution
GS1	20812460027701 [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.

Trademark Results [Rospital Productos Medicos]

Mark Image Registration \| Serial	Company Trademark Application Date
ROSPITAL PRODUCTOS MEDICOS 86096236 not registered Dead/Abandoned	ATLAS MEDICAL PRODUCTS LLC 2013-10-20