Collecting Bag 2000ml (Straub Medical®) 10170

GUDID 07640142810612

The collecting bag is non-patient contacting and is attached to the silicon outflow tube on the proximal end of the catheter. The fluid aspirated by the catheter passes through the catheters’ outflow tubing into the Collecting bag.

Straub Medical AG

Non-wearable urine collection bag, closed-ended Non-wearable adult urine collection bag, closed-ended Non-wearable adult urine collection bag, closed-ended Non-wearable adult urine collection bag, closed-ended Non-wearable adult urine collection bag, closed-ended Non-wearable adult urine collection bag, closed-ended Non-wearable adult urine collection bag, closed-ended Non-wearable adult urine collection bag, closed-ended Non-wearable adult urine collection bag, closed-ended Non-wearable adult urine collection bag, closed-ended Non-wearable adult urine collection bag, closed-ended Non-wearable adult urine collection bag, closed-ended Non-wearable adult urine collection bag, closed-ended Non-wearable adult urine collection bag, closed-ended Non-wearable adult urine collection bag, closed-ended Non-wearable adult urine collection bag, closed-ended Non-wearable adult urine collection bag, closed-ended Non-wearable adult urine collection bag, closed-ended Non-wearable adult urine collection bag, closed-ended Non-wearable adult urine collection bag, closed-ended Non-wearable adult urine collection bag, closed-ended Non-wearable adult urine collection bag, closed-ended Non-wearable adult urine collection bag, closed-ended Non-wearable adult urine collection bag, closed-ended Non-wearable adult urine collection bag, closed-ended Non-wearable adult urine collection bag, closed-ended Non-wearable adult urine collection bag, closed-ended
Primary Device ID07640142810612
NIH Device Record Key3a30fe23-eb0a-45a3-82d8-6ec76fe85264
Commercial Distribution StatusIn Commercial Distribution
Brand NameCollecting Bag 2000ml (Straub Medical®)
Version Model NumberVersion 1.0
Catalog Number10170
Company DUNS488489766
Company NameStraub Medical AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com
Phone+41817200460
Emailinfo@straubmedical.com

Device Dimensions

Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter
Total Volume2000 Milliliter

Device Identifiers

Device Issuing AgencyDevice ID
GS107640142810612 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNXCollector, Urine, (And Accessories) For Indwelling Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-10
Device Publish Date2020-01-31

Devices Manufactured by Straub Medical AG

07640142810407 - Aspirex® S 6F 110 cm 2022-07-08 The Aspirex® S catheter (gauge 6F; length 110cm) is over-the-wire, single use, percutaneous device for the treatment of occlusi
07640142810438 - Aspirex® S 6F 135cm 2022-07-08 The Aspirex® S catheter (gauge 6F; length 135cm) is over-the-wire, single use, percutaneous device for the treatment of occlusi
07640142810452 - Aspirex® S 8F 85cm 2022-07-08 The Aspirex® S catheter (gauge 8F; length 85cm) is over-the-wire, single use, percutaneous device for the treatment of occlusio
07640142810483 - Aspirex® S 8F 110cm 2022-07-08 The Aspirex® S catheter (gauge 8F; length 110cm) is over-the-wire, single use, percutaneous device for the treatment of occlusi
07640142810506 - Aspirex® S 10F 110cm 2022-07-08 The Aspirex® S catheter (gauge 10F; length 110cm) is over-the-wire, single use, percutaneous device for the treatment of occlus
07640142810735 - Guidewire 0.025 6/270cm angled 2022-07-08 The Rotarex™ S and Aspirex™ S Guidewire has a LubriSkin PTFE-coated nitinol core wire with a gold-plated Tungsten tip coated
07640142811312 - SET Aspirex™ S 6F 110cm2022-07-08 The Aspirex™ S Thrombectomy Catheter Set is composed of one Aspirex™ S Thrombectomy Catheter (gauge 6F; length 110cm), one A
07640142811329 - SET Aspirex™ S 6F 135cm2022-07-08 The Aspirex™ Thrombectomy Catheter Set is composed of one Aspirex™ Thrombectomy Catheter (gauge 6F; length 135cm), one Aspir

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.