FDA.reportPublic FDA data

SIMPULSE

Primary DI
00801741065323
Brand
SIMPULSE
Company
Davol Inc.
Model
0067310
Catalog number
0067310
Device description
VariCare Retractable Small Splash Shield Wound Tip
Published
2015-12-23
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
FQHLAVAGE, JET

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQHLavage, JetGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10801741065320PackageGS110Not in Commercial Distribution
00801741065323PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174106532010801741065320
00801741065323008017410653238017410653230801741065323

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation/aspiration pump, single-useAn electrically-powered device intended to both irrigate and aspirate (i.e., capable of both functions) body cavities and wounds typically during an endoscopic and/or orthopaedic surgical procedure, in conjunction with a patient contact device (not included), usually to facilitate observation. It is intended to remove tissues/fluids/debris through suction, and to irrigate the surgical site with a sterile fluid (e.g., saline); it is not intended to administer parenteral fluids or drugs. The device may include noninvasive accessories (e.g., collection container, tubing); it does not include patient contact devices (e.g., handpiece/tip, catheter). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)562-0027medical.services@bd.com

Regulatory Flags#

DUNS number
001191048
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801741233279GalaFLEX 3DRFR3D02BDFR3D02BD2026-04-30
10801741233521GalaFLEX 3DSH3D02BDSH3D02BD2026-04-30
10801741234368GalaFLEX 3DSH3D04BDSH3D04BD2026-04-30
10801741234382GalaFLEX 3DSH3D06BDSH3D06BD2026-04-30
10801741234412GalaFLEX 3DRFR3D04BDFR3D04BD2026-04-30
10801741234436GalaFLEX 3DRFR3D06BDFR3D06BD2026-04-30
00801741074318OPTIFIX011312601131262015-04-16
00801741074325OPTIFIX011312701131272015-04-16
00801741233265GalaFLEX 3DRFR3D01BDFR3D01BD2026-04-30
00801741233494GalaFLEX 3DSH3D01BDSH3D01BD2026-04-30
00801741234354GalaFLEX 3DSH3D03BDSH3D03BD2026-04-30
00801741234378GalaFLEX 3DSH3D05BDSH3D05BD2026-04-30
00801741234392GalaFLEX 3DSH3D07BDSH3D07BD2026-04-30
00801741234408GalaFLEX 3DRFR3D03BDFR3D03BD2026-04-30
00801741234422GalaFLEX 3DRFR3D05BDFR3D05BD2026-04-30
00801741074431ONFLEX011541101154112015-07-17
00801741074424ONFLEX011541001154102015-07-17
00801741010507Avitene101034010103402014-09-12
00801741065439SURETRANS859500085950002015-06-17
00801741000386Avitene101002010100202014-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B674PL30010PerilavStiehl Tech, LLCFQH2026-05-13
B674T93LF10PerilavStiehl Tech, LLCFQH2026-05-13
07640407460811debritom+Medaxis AGFQH2026-04-17
07649996166302debritom+Medaxis AGFQH2026-04-17
07649996166043debritom+Medaxis AGFQH2026-04-08
04050147023826ErbeErbe Elektromedizin GmbHFQH2026-04-01
00382909101201SurgiphorCAREFUSION 2200, INCFQH2026-03-05
00075450844337Hy-Vee Saline Wound WashHY-VEE, INC.FQH2026-02-19
00850073677032Shur-ClensAsept Pak, Inc.FQH2026-02-17
00850073677056Skin-ClensAsept Pak, Inc.FQH2026-02-17
04050147022959ErbeErbe Elektromedizin GmbHFQH2025-10-01
04050147022942ErbeErbe Elektromedizin GmbHFQH2025-09-30
10850073677008Shur-ClensAsept Pak, Inc.FQH2025-04-30
10860006476035Shur-ClensAsept Pak, Inc.FQH2025-04-23
10850073677015Shur-ClensAsept Pak, Inc.FQH2025-04-16
10860006476028Shur-ClensAsept Pak, Inc.FQH2025-04-16
10842351180027Irrisept Accessory KitIRRIMAX CORPORATIONFQH2024-07-22
10842351120047Irrisept Antimicrobial Wound LavageIRRIMAX CORPORATIONFQH2024-07-16
10842351180010Irrisept Wound Solution KitIRRIMAX CORPORATIONFQH2024-07-01
03600040955086ElefantColoplast A/SFQH2024-04-05
03600040955116ElefantColoplast A/SFQH2024-04-05
03600040970614ElefantColoplast A/SFQH2024-04-05
03600040970645ElefantColoplast A/SFQH2024-04-05
03600040970676ElefantColoplast A/SFQH2024-04-05
03600040970737ElefantColoplast A/SFQH2024-04-05
03600040970768ElefantColoplast A/SFQH2024-04-05
03600040970799ElefantColoplast A/SFQH2024-04-05
00034197018470Premier Solution Saline Wound WashPremier Brands of America Inc.FQH2024-03-12
00032251985164Family Wellness Saline Wound WashFamily Dollar StoresFQH2024-03-10
00856276008468VitaleCELLERA LLCFQH2023-08-10