FDA.reportPublic FDA data

Collecting Bag 2000ml (Straub Medical®)

Primary DI
07640142810612
Brand
Collecting Bag 2000ml (Straub Medical®)
Company
Straub Medical AG
Model
Version 1.0
Catalog number
10170
Device description
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.
Published
2020-01-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNXCollector, Urine, (And Accessories) For Indwelling Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNXCollector, Urine, (And Accessories) For Indwelling CatheterGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172315000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172315000Straub Endovascular SystemStraub Medical AG2018-04-12MCW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640142810612PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640142810612076401428106127640142810612

GMDN Terms#

Term, Definition table
TermDefinition
Non-wearable urine collection bag, closed-endedA flexible plastic pouch designed to connect to a urinary catheter to collect discharged urine from a patient; it is not designed with an opening for urine drainage. The device is not directly attached to the patient and is disposed of when full. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume2000Milliliter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+41817200460info@straubmedical.com

Regulatory Flags#

DUNS number
488489766
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640142811305Guidewire 0.025 6/270cm angled 80265802652022-06-30
07640142810407Aspirex® S 6F 110 cm 80209802092022-06-30
07640142810438Aspirex® S 6F 135cm 80203802032022-06-30
07640142810452Aspirex® S 8F 85cm 80210802102022-06-30
07640142810483Aspirex® S 8F 110cm 80204802042022-06-30
07640142810506Aspirex® S 10F 110cm 80211802112022-06-30
07640142811817Rotarex™S 6 F x 110 cm 80332803322022-05-04
07640142811824Rotarex™S 6 F x 135 cm80333803332022-05-04
07640142811831Rotarex™S 8 F x 85 cm80334803342022-05-04
07640142811848Rotarex™S 8 F x 110 cm 80335803352022-05-04
07640142811855SET Rotarex™S 6 F x 110 cm80236802362022-05-04
07640142811862SET Rotarex™S 6 F x 135 cm 80237802372022-05-04
07640142811879SET Rotarex™S 8 F x 85 cm 80238802382022-05-04
07640142811886SET Rotarex™S 8 F x 110 cm80239802392022-05-04
07640142810278Rotarex®S 6F 110cm (Straub Medical®)Version 1.0802082020-02-07
07640142810292Rotarex®S 6F 135cm (Straub Medical®)Version 1.0802012020-02-07
07640142810353Rotarex®S 8F 85cm (Straub Medical®)Version 1.0802062020-02-07
07640142810384Rotarex®S 8F 110cm (Straub Medical®)Version 1.0802072020-02-07
07640142810193Drape, sterile for motor or footswitch (Straub Medical®)Version 1.0800682020-01-31
07640142810247Guidewire 0.018 4/220cm angled (Straub Medical®)Version 1.0802332020-01-31

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