FDA.reportPublic FDA data

Jigsaw Medical,LLC

Primary DI
00856274008620
Brand
Jigsaw Medical,LLC
Company
JIGSAW MEDICAL, LLC
Model
SV1000-SPWC
Device description
Sterile Pathway Spike Safety-Vac 1000+ Pre-Vac Wound Drainage Bottle 1000ml With Clave
Published
2023-06-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCYApparatus, Suction, Single Patient Use, Portable, NonpoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856274008637PackageGS112In Commercial Distribution
00856274008620PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856274008637008562740086378562740086370856274008637
00856274008620008562740086208562740086200856274008620

GMDN Terms#

Term, Definition table
TermDefinition
Closed-wound/centesis drainage receptacleA sterile container designed to be connected to an invasive drain/drainage catheter (not included) to collect fluids or purulent material being removed during drainage of a body cavity, a closed-wound, and/or the bile duct; it is not intended for drainage of cerebrospinal fluid (CSF) or blood. It is typically in the form of a bottle, bag, or bulb with fluid volume markers, and might include a hand-operated pump (e.g., suction bulb) and tubing; it does not include any invasive components or powered devices. This is a single-use device.

Regulatory Flags#

DUNS number
079233827
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856274008637Jigsaw Medical,LLCSV1000-SPWC2023-06-28
00856274008026Jigsaw Medical,LLCPK52218PK522182019-09-20
00856274008170Jigsaw Medical,LLCSVCT47-S2020-09-23
00856274008194Jigsaw Medical,LLCSVHFDT-S2020-09-23
00856274008217Jigsaw Medical,LLCSVA47-S2020-09-23
00856274008569Jigsaw Medical,LLCSVHFSP-S2021-04-05
00856274008606Jigsaw Medical,LLCSV1000-NSWC2022-02-16
00856274008613Jigsaw Medical,LLCSV1000-NSWC2022-02-16
00856274008316Jigsaw Medical, LLCTD1822TD18222019-09-25
00856274008323Jigsaw Medical, LLCTD3012TD30122019-09-25
00856274008378Jigsaw Medical, LLCTD1310TD13102019-09-25
00856274008408Jigsaw Medical, LLCTD3023TD30232019-09-25
00856274008439Jigsaw Medical, LLCTD0605TD06052019-09-25
00856274008460Jigsaw Medical,LLCKT100KT1002019-12-09
00856274008484Jigsaw Medical,LLCKT103KT1032019-12-09
00856274008507Jigsaw Medical,LLCKT101KT1012019-12-09
00856274008521Jigsaw Medical,LLCKT102KT1022019-12-09
00856274008576Jigsaw Medical,LLCSVHFSP-S2021-04-05
00856274008545Jigsaw Medical,LLCSV1000-SSP2020-09-24
00856274008590Jigsaw Medical,LLC801502020-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09420060206036haakaaTHINK GREEN LIMITEDGCY2026-09-20
09420060206043haakaaTHINK GREEN LIMITEDGCY2026-09-20
09420060206050haakaaTHINK GREEN LIMITEDGCY2026-09-20
09420060206067haakaaTHINK GREEN LIMITEDGCY2026-09-20
04710969717906Uresil Evolution PRE.VAC WOUND DRAINAGE BOTTLE 1000 mL, with Connecting TubeCanadian Hospital Specialties LimitedGCY2026-08-18
04710969717913Uresil Evolution PRE.VAC WOUND DRAINAGE BOTTLE 1000 mLCanadian Hospital Specialties LimitedGCY2026-08-18
04710969717920Uresil Evolution Connecting TubeCanadian Hospital Specialties LimitedGCY2026-08-18
04719899159787Uresil Evolution PRE.VAC WOUND DRAINAGE BOTTLE 1000 mLCanadian Hospital Specialties LimitedGCY2026-08-18
04719899159794Uresil Evolution PRE-VAC WOUND DRAINAGE BOTTLECanadian Hospital Specialties LimitedGCY2026-08-18
04719899159824Uresil Evolution Connecting Tube, with SpikeCanadian Hospital Specialties LimitedGCY2026-08-18
08718104890954Exsudex disposable canisterMeditop B.V.GCY2025-10-17
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00848530095222Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
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00848530106225Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00848530106232Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00848530106256Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00848530106263Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00848530106270Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCY2025-06-03
00848530104467Suction KitSunset Healthcare Solutions, Inc.GCY2025-04-14