FDA.reportPublic FDA data

Surge Cardiovascular

Primary DI
10817278012492
Brand
Surge Cardiovascular
Company
Alliant Enterprises, LLC
Model
SUC-0840
Catalog number
SUC-0840
Device description
Cardiac Sucker, flexible, fluted tip, 1/4" connector, 14.5" length, non-sterile
Published
2018-03-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCXApparatus, Suction, Operating-Room, Wall Vacuum PoweredGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K971022000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K971022000CHASE SUCKERChase Medical, Inc.1997-04-17GCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817278012492PackageGS1100In Commercial Distribution
00817278012495PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081727801249210817278012492
00817278012495008172780124958172780124950817278012495

GMDN Terms#

Term, Definition table
TermDefinition
Suction system catheter, general-purposeA sterile flexible tube used in the removal of fluids from the body via a natural body orifice, surgical incision, or wound. It is typically designed to be attached to a collection canister or bottle where a vacuum is created by a suction system via an intermediate tubing. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
121170653
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817278010132Surge Cardiovascular213-0251213-02512016-09-23
00817278010149Surge Cardiovascular213-026213-0262016-09-23
00817278010897Surge CardiovascularPER-1407S-C02PER-1407S-C022016-09-23
00817278010903Surge CardiovascularPER-1401S-C05PER-1401S-C052016-09-23
00817278011269Surge CardiovascularSSD-100ASSD-100A2016-09-23
00817278011696Surge Cardiovascular5756NS5756NS2018-03-27
00817278011979Surge Cardiovascular213-028213-0282016-09-23
00817278011986Surge Cardiovascular213-0252213-02522016-09-23
00817278012396Terumo Cardiovascular SystemsT402210T4022102018-04-25
00817278011276Surge CardiovascularSUC-4300SUC-43002016-09-23
00817278011757Surge CardiovascularSUC-0840SUC-08402016-09-23
10817278010009Surge CardiovascularSUT-010SUT-0102016-09-23
10817278010016Surge CardiovascularSUT-013SUT-0132016-09-23
10817278010023Surge Cardiovascular213-013213-0132016-09-23
10817278010887Surge CardiovascularSUT-014SUT-0142016-09-23
10817278011952MicroSurgeSUT-M110SUT-M1102016-09-23
10817278011969MicroSurgeSUT-M114SUT-M1142016-09-23
10817278010115Surge Cardiovascular213-002213-0022016-09-23
10817278010122Surge Cardiovascular213-004213-0042016-09-23
10817278010955Surge Cardiovascular213-003213-0032016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956310698CARDINAL HEALTHCardinal Health 200, LLCGCX2026-04-06
10198956435629CARDINAL HEALTHCardinal Health 200, LLCGCX2026-04-06
10198956355477CARDINAL HEALTHCardinal Health 200, LLCGCX2026-03-19
10198956417991CARDINAL HEALTHCardinal Health 200, LLCGCX2026-03-16
10198956375642CARDINAL HEALTHCardinal Health 200, LLCGCX2026-02-13
10198956277939CARDINAL HEALTHCardinal Health 200, LLCGCX2026-01-22
10198956289284CARDINAL HEALTHCardinal Health 200, LLCGCX2026-01-12
10198956261808CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-17
10192253043365CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043372CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043389CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043396CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043402CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043419CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10198956252127CARDINAL HEALTHCardinal Health 200, LLCGCX2025-11-25
08682952420093DeRoyalPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-11-06
10198956241909CARDINAL HEALTHCardinal Health 200, LLCGCX2025-11-04
10198956242098CARDINAL HEALTHCardinal Health 200, LLCGCX2025-10-22
10198956160859CARDINAL HEALTHCardinal Health 200, LLCGCX2025-08-27
10198956180383CARDINAL HEALTHCardinal Health 200, LLCGCX2025-08-27
10198459423567MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.GCX2025-07-21
10198459398063MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.GCX2025-07-07
10198956073883CARDINAL HEALTHCardinal Health 200, LLCGCX2025-07-04
10198956033252CARDINAL HEALTHCardinal Health 200, LLCGCX2025-06-12
10198956087279CARDINAL HEALTHCardinal Health 200, LLCGCX2025-06-11
10198956097728CARDINAL HEALTHCardinal Health 200, LLCGCX2025-06-05
10198956083790CARDINAL HEALTHCardinal Health 200, LLCGCX2025-05-14
08682952418014PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-05-13
10198956013704CARDINAL HEALTHCardinal Health 200, LLCGCX2025-05-09
08682952418144DeRoyalPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-05-08