Rospital Productos Medicos CCA06
GUDID 10812460028688
FOLEY CATHETER, 2 WAY 22FR, 15 ML, 100% SILICONE. 10/BX.
ATLAS MEDICAL PRODUCTS LLC
Indwelling urethral drainage catheter, non-antimicrobial| Primary Device ID | 10812460028688 |
| NIH Device Record Key | 64f3b6b3-5946-40d2-aad2-7ccda28cea6a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Rospital Productos Medicos |
| Version Model Number | CCA06 |
| Catalog Number | CCA06 |
| 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
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 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 | 00812460028681 [Primary] |
| GS1 | 10812460028688 [Package] Contains: 00812460028681 Package: INNER BOX [10 Units] In Commercial Distribution |
| GS1 | 20812460028685 [Package] Package: CASE [20 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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-26 |
| Device Publish Date | 2020-10-18 |
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 |
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