FDA.report

Simpulse VariCare

Primary DI
10801741065337
Brand
Simpulse VariCare
Company
Davol Inc.
Model
0067320
Catalog number
0067320
Device description
VariCare Retractable Splash Shield Wound Tip
Published
2015-12-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FQHLAVAGE, JET

Product Code Classifications

CodeDeviceSpecialtyClass
FQHLavage, JetGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10801741065337PackageGS110In Commercial Distribution
00801741065330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174106533710801741065337
00801741065330008017410653308017410653300801741065330

GMDN Terms

TermDefinition
Surgical irrigation/aspiration systemAn assembly of devices used to intermittently or continuously irrigate and/or aspirate body cavities and wounds during a general surgical procedure. It provides for the removal of loose tissue, fluids, and other debris to keep the surgical site clear, helping to optimize visualization and access. The assembly typically includes a mains electricity (AC-powered) pump, collection bottles, tubing, and connectors. It may be used together with an irrigation catheter. It is not intended to be used for the administration of parenteral fluids, infusion of drugs, or for any life sustaining purposes.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)562-0027medical.services@crbard.com
+1(800)562-0027medical.services@bd.com

Regulatory Flags

DUNS number
001191048
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00801741233678GalaFLEXGP0103BDGP0103BD2025-09-25
00801741233685GalaFLEXGP0206BDGP0206BD2025-09-25
00801741233692GalaFLEXGP0208BDGP0208BD2025-09-25
00801741233708GalaFLEXGP0408BDGP0408BD2025-09-25
00801741233715GalaFLEXGP0608BDGP0608BD2025-09-25
00801741233722GalaFLEX LITEGFLT0207BDGFLT0207BD2025-09-25
00801741233739GalaFLEX LITEGFLT0515BDGFLT0515BD2025-09-25
00801741233746GalaFLEX LITEGFLT0520BDGFLT0520BD2025-09-25
00801741233753GalaFLEX LITEGFLT0013BDGFLT0013BD2025-09-25
00801741233760GalaFLEX LITEGFLT1020BDGFLT1020BD2025-09-25
00801741233777GalaFLEX LITEGFLT0015BDGFLT0015BD2025-09-25
00801741233784GalaFLEX LITEGFLT0017BDGFLT0017BD2025-09-25
00801741233791GalaFLEX LITEGFLT1520BDGFLT1520BD2025-09-25
00801741233814GalaFLEX LITEGFLT0019BDGFLT0019BD2025-09-25
00801741233821GalaFLEX LITEGFLT0022BDGFLT0022BD2025-09-25
00801741233838GalaFLEX LITEGFLT0025BDGFLT0025BD2025-09-25
00801741233852GalaFLEX LITEGFLT2025BDGFLT2025BD2025-09-25
00801741234019GalaFLEX LITEGFLT2530BDGFLT2530BD2025-09-25
00801741226519Phasix123000712300072025-02-24
00801741226533Phasix123000912300092025-02-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
50382909101206SurgiphorCAREFUSION 2200, INCFQH2026-03-05
10075450844334Hy-Vee Saline Wound WashHY-VEE, INC.FQH2026-02-19
10850073677039Shur-ClensAsept Pak, Inc.FQH2026-02-17
00850073677063Skin-ClensAsept Pak, Inc.FQH2026-02-17
06970462546825Irrigation PumpShenzhen HugeMed Medical Technical Development Co., Ltd.FQH2026-02-10
15051471214788De Soutter MedicalDE SOUTTER MEDICAL LIMITEDFQH2025-09-12
15051471214795De Soutter MedicalDE SOUTTER MEDICAL LIMITEDFQH2025-09-12
15051471217123De Soutter MedicalDE SOUTTER MEDICAL LIMITEDFQH2025-09-12
15051471217130De Soutter MedicalDE SOUTTER MEDICAL LIMITEDFQH2025-09-12
00810025928858Caring Mill Saline Wound WashCaring MillFQH2025-07-03
20850073677005Shur-ClensAsept Pak, Inc.FQH2025-04-30
00860006476038Shur-ClensAsept Pak, Inc.FQH2025-04-23
00842351120040Irrisept Antimicrobial Wound LavageIRRIMAX CORPORATIONFQH2024-07-16
ESUM930081200SutterSutter Medizintechnik GmbHFQH2024-06-24
00817278012020Patriot ProMed Michigan Holdings, LLCFQH2024-06-04
05051471211735De Soutter MedicalDE SOUTTER MEDICAL LIMITEDFQH2024-05-21
05051471211742De Soutter MedicalDE SOUTTER MEDICAL LIMITEDFQH2024-05-21
06951233720125CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720170CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720316CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720330CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720361CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720378palaJet ®Guangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720507palaJet ®Guangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720545CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720569PulsaCleanGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720958PulsaCleanGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233720965PulsaCleanGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233721085CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11
06951233721108CLEANESTGuangzhou Clean Medical Products Manufacturing Corp.FQH2024-04-11