FDA.reportPublic FDA data

Jigsaw Medical,LLC

Primary DI
00856274008637
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
Rx
false
OTC
true
Sterile
false
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079233827
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856274008620Jigsaw 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
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
10198956231788CARDINAL HEALTHCardinal Health 200, LLCGCY2025-10-20
08718104890954Exsudex disposable canisterMeditop B.V.GCY2025-10-17
50192253042748ArgyleCardinal Health 200, LLCGCY2025-10-02
50192253042755ArgyleCardinal Health 200, LLCGCY2025-10-02
10198956012769CARDINAL HEALTHCardinal Health 200, LLCGCY2025-03-26
10197106675588CARDINAL HEALTHCardinal Health 200, LLCGCY2024-05-22
10197106600788CARDINAL HEALTHCardinal Health 200, LLCGCY2024-03-25
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