FDA.reportPublic FDA data

Tur Vac

Primary DI
00812261019413
Brand
Tur Vac
Company
ALLWIN MEDICAL DEVICES, INC.
Model
Bladder Evacuator
Catalog number
TV
Device description
Tur Vac Bladder Evacuator
Published
2020-09-22
Public version status
New
Distribution status
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
KQTEvacuator, Gastro-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQTEvacuator, Gastro-UrologyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812261019413PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812261019413008122610194138122610194130812261019413

GMDN Terms#

Term, Definition table
TermDefinition
Bladder evacuator, single-useA sterile, hand-operated device that is attached to a resectoscope and used to suction tissue and body fluids that are released during a transurethral resection (TUR) procedure. It typically consists of a glass or plastic container, a squeeze bulb, tubing and a connector/adaptor for connection to the resectoscope. It is filled with sterile water and vigorously squeezed to force the water through the resectoscope to irrigate and evacuate tissue fragments, blood clots, or calculi from the urinary bladder; these are caught and trapped within the evacuator so as not to be returned to the bladder when the device is squeezed again. Commonly known as an Ellik evacuator. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
714-572-1709info@allwinmedical.com

Regulatory Flags#

DUNS number
796354509
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812261016597ASPIASPI Aspiration NeedleASPI22/302024-01-09
00819374021746SURESTRIPSURESTRIP Vitrification StrawSUS-Y2024-01-10
00812261010069allSoftallSoft Ureteral Stent Open TipSOT5/242024-01-09
00812261010823allSoftallSoft Pediatric Ureteral Stents Open Tip 3F, 10cPOS3/102024-01-09
00812261010830allSoftallSoft Pediatric Ureteral Stents Open Tip 3F, 12cPOS3/122024-01-09
00812261010847allSoftallSoft Pediatric Ureteral Stents Open Tip 3F, 14cPOS3/142024-01-09
00812261010854allSoftallSoft Pediatric Ureteral Stents Open Tip 3F, 16cPOS3/162024-01-09
00812261010861allSoftallSoft Pediatric Ureteral Stents Open Tip 4F, 10cPOS4/102024-01-09
00812261010878allSoftallSoft Pediatric Ureteral Stents Open Tip 4F, 12cPOS4/122024-01-09
00812261010885allSoftallSoft Pediatric Ureteral Stents Open Tip 4F, 14cPOS4/142024-01-09
00812261010892allSoftallSoft Pediatric Ureteral Stents Open Tip 4F, 16cPOS4/162024-01-09
00812261010908allSoftallSoft Pediatric Ureteral Stents Open Tip 3F, 10cPOS3/10-G2024-01-09
00812261010915allSoftallSoft Pediatric Ureteral Stents Open Tip 3F, 12cPOS3/12-G2024-01-09
00812261010922allSoftallSoft Pediatric Ureteral Stents Open Tip 3F, 14cPOS3/14-G2024-01-09
00812261010939allSoftallSoft Pediatric Ureteral Stents Open Tip 3F, 16cPOS3-16-G2024-01-09
00812261010946allSoft allSoft Pediatric Ureteral Stents Open Tip 4F, 10cPOS4/10-G2024-01-09
00812261010953allSoftallSoft Pediatric Ureteral Stents Open Tip 4F, 12cPOS4/12-G2024-01-09
00812261010960allSoftallSoft Pediatric Ureteral Stents Open Tip 4F, 14cPOS4/14-G2024-01-09
00812261010977allSoftallSoft Pediatric Ureteral Stents Open Tip 4F, 16cPOS4/16-G2024-01-09
00812261011806allDrainallDrain Percutaneous Nephrostomy Catheter PigtailPCN-P142024-01-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04055207054390NARichard Wolf GmbHKQT2026-05-19
06973356557754TriousShenzhen Trious Medical Technology Co., Ltd.KQT2026-03-25
06973356557907PUSENShenzhen Trious Medical Technology Co., Ltd.KQT2025-12-08
04055207011911NARichard Wolf GmbHKQT2024-08-19
00724995203306BioVacUS EndoscopyKQT2020-11-23
10724995203303BioVacUS EndoscopyKQT2020-11-23
00801741049057Ellik Bladder EvacuatorC. R. Bard, Inc.KQT2020-09-22
00801741080647Bladder EvacuatorC. R. Bard, Inc.KQT2020-09-22
00724995183783BioVacUS EndoscopyKQT2020-04-01
00724995183790BioVacUS EndoscopyKQT2020-04-01
00724995183806BioVacUS EndoscopyKQT2020-04-01
10724995183780BioVacUS EndoscopyKQT2020-04-01
10724995183797BioVacUS EndoscopyKQT2020-04-01
10724995183803BioVacUS EndoscopyKQT2020-04-01
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00860002476148Intussusception Air Reduction Bulb & Gauge with Plastic CaseGRI MEDICAL PRODUCTS INCKQT2019-12-18
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00821925001053ToomeyGyrus ACMI, LLCKQT2016-10-11
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00821925002593Gyrus ACMIGyrus ACMI, LLCKQT2016-10-11
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