FDA.reportPublic FDA data

Axiom® Sump-n-Sheath®

Primary DI
M6651111560
Brand
Axiom® Sump-n-Sheath®
Company
AXIOM MEDICAL, INCORPORATED
Model
111156
Device description
Sump-n-Sheath®, Sump Drain, Two Lumens, Silicone, Large Eye, With Silicone Penrose, With Suture Ring
Published
2018-09-23
Public version status
New
Distribution status
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
FEGTube, Double Lumen For Intestinal Decompression And/Or Intubation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEGTube, Double Lumen For Intestinal Decompression And/Or IntubationGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K771048000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K771048000CATHETERS, DRAINAGEAxiom Medical, Inc.1977-07-19FEG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M6651111561PackageHIBCC10In Commercial Distribution
M6651111563PackageHIBCC10In Commercial Distribution
M6651111560PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Sump drainA sterile, tube-like device that has a double lumen which is designed to establish a channel for the removal of fluids from a cavity by allowing air to enter the cavity through the smaller lumen which displaces fluid into the larger lumen. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length18Inch
Lumen/Inner Diameter0.5Inch
Lumen/Inner Diameter7Millimeter

Contacts#

Phone, Email table
PhoneEmail
310-533-9020Sales@AxiomMed.com

Regulatory Flags#

DUNS number
094439676
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M6651000080Axiom®1000082016-09-23
M665100008AT0Axiom® Atraum™ With ClotStop®100008AT2018-09-23
M665100008ATS0Axiom® Atraum™ With ClotStop®100008ATS2018-09-23
M665100008ATSC0Axiom® Atraum™ With ClotStop®100008ATSC2018-09-23
M665100008S0Axiom®100008S2016-09-23
M665100008SC0Axiom®100008SC2016-09-23
M6651000100Axiom®1000102016-09-23
M665100010AT0Axiom® Atraum™ With ClotStop®100010AT2018-09-23
M665100010ATS0Axiom® Atraum™ With ClotStop®100010ATS2018-09-23
M665100010ATSC0Axiom® Atraum™ With ClotStop®100010ATSC2018-09-23
M665100010S0Axiom®100010S2016-09-23
M665100010SC0Axiom®100010SC2016-09-23
M6651000120Axiom®1000122016-09-23
M665100012AT0Axiom® Atraum™ With ClotStop®100012AT2018-09-23
M665100012ATS0Axiom® Atraum™ With ClotStop®100012ATS2018-09-23
M665100012ATSC0Axiom® Atraum™ With ClotStop®100012ATSC2018-09-23
M665100012S0Axiom®100012S2016-09-23
M665100012SC0Axiom®100012SC2016-09-23
M6651000140Axiom®1000142016-09-23
M665100014AT0Axiom® Atraum™ With ClotStop®100014AT2018-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253012460Salem SumpCardinal Health 200, LLCFEG2026-03-19
10192253012484Salem SumpCardinal Health 200, LLCFEG2026-03-19
10192253012507Salem SumpCardinal Health 200, LLCFEG2026-03-19
10192253012521Salem SumpCardinal Health 200, LLCFEG2026-03-19
10192253012989Salem SumpCardinal Health 200, LLCFEG2026-03-19
10192253013009Salem SumpCardinal Health 200, LLCFEG2026-03-19
10192253060928Salem SumpCardinal Health 200, LLCFEG2026-03-19
50192253012468Salem SumpCardinal Health 200, LLCFEG2026-03-19
50192253012482Salem SumpCardinal Health 200, LLCFEG2026-03-19
50192253012529Salem SumpCardinal Health 200, LLCFEG2026-03-19
50192253013007Salem SumpCardinal Health 200, LLCFEG2026-03-19
50192253060926Salem SumpCardinal Health 200, LLCFEG2026-03-19
10192253006872Salem SumpCardinal Health 200, LLCFEG2026-01-16
10192253006889Salem SumpCardinal Health 200, LLCFEG2026-01-16
10192253006902Salem SumpCardinal Health 200, LLCFEG2026-01-16
10192253012767Salem SumpCardinal Health 200, LLCFEG2026-01-16
50192253006870Salem SumpCardinal Health 200, LLCFEG2026-01-16
50192253006887Salem SumpCardinal Health 200, LLCFEG2026-01-16
50192253006900Salem SumpCardinal Health 200, LLCFEG2026-01-16
50192253012765Salem SumpCardinal Health 200, LLCFEG2026-01-16
10810141932545VIVIT SupplyVivit Supply LLCFEG2024-10-04
20810141932542VIVIT SupplyVivit Supply LLCFEG2024-10-04
10884521740693Salem SumpCardinal Health, Inc.FEG2024-03-11
10884521740709Salem SumpCardinal Health, Inc.FEG2024-03-11
10884521740716Salem SumpCardinal Health, Inc.FEG2024-03-11
10884521740723Salem SumpCardinal Health, Inc.FEG2024-03-11
10884521740730Salem SumpCardinal Health, Inc.FEG2024-03-11
20884521740690Salem SumpCardinal Health, Inc.FEG2024-03-11
20884521740720Salem SumpCardinal Health, Inc.FEG2024-03-11
10884389965757MedlineMEDLINE INDUSTRIES, INC.FEG2024-02-16