FDA.reportPublic FDA data

Axiom®

Primary DI
M6651018630
Brand
Axiom®
Company
AXIOM MEDICAL, INCORPORATED
Model
101863
Device description
Penrose Tubing, Silicone
Published
2016-09-23
Public version status
Update
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
KDHCatheter (Gastric, Colonic, Etc.), Irrigation And Aspiration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDHCatheter (Gastric, Colonic, Etc.), Irrigation And AspirationGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K781749000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K781749000TUBING, AXIOM SILICONE PENROSEAxiom Medical, Inc.1978-12-04KDH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M6651018631PackageHIBCC10In Commercial Distribution
M6651018633PackageHIBCC10In Commercial Distribution
M6651018630PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical capillary wound drain, luminal, synthetic polymerA sterile device with a lumen(s) designed to establish a passive egress for the removal of fluid (drainage of blood, lymph, exudate) from a surgical wound to minimize its accumulation and risk of wound infection; it is not dedicated to a particular anatomical wound. It is typically inserted into the wound by a surgeon in the operating room (OR) after the completion of an inpatient or outpatient procedure. It is typically made of radiopaque silicone and is available in various forms (e.g., Penrose type, tubular with side holes, multi-tubular). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length18Inch
Lumen/Inner Diameter0.625Inch

Contacts#

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

Regulatory Flags#

DUNS number
094439676
Device count
1
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
10850082007100Aspiration TubingARMM INC.KDH2023-06-08
10850082007117Aspiration TubingARMM INC.KDH2023-06-08
10850082007124Aspiration TubingARMM INC.KDH2023-06-08
00850082007103Aspiration TubingARMM INC.KDH2023-06-08
00850082007110Aspiration TubingARMM INC.KDH2023-06-08
00850082007127Aspiration TubingARMM INC.KDH2023-06-08
10192253013016ArgyleCardinal Health 200, LLCKDH2022-10-26
10192253013023ArgyleCardinal Health 200, LLCKDH2022-10-26
50192253013014ArgyleCardinal Health 200, LLCKDH2022-10-26
50192253013021ArgyleCardinal Health 200, LLCKDH2022-10-26
00350770927961Aspiration CatheterAvanos Medical, Inc.KDH2019-09-10
10350770927968AVANOSAvanos Medical, Inc.KDH2019-09-10
00350770927749Injection Needle CatheterAvanos Medical, Inc.KDH2019-07-27
00350770927756Injection Needle CatheterAvanos Medical, Inc.KDH2019-07-27
00350770927800Injection Needle CatheterAvanos Medical, Inc.KDH2019-07-27
10350770927746AVANOSAvanos Medical, Inc.KDH2019-07-27
10350770927753AVANOSAvanos Medical, Inc.KDH2019-07-27
10350770927807AVANOSAvanos Medical, Inc.KDH2019-07-27
00815277020084CuraplexBOUND TREE MEDICAL, LLCKDH2016-12-16
00827002165717SilberCOOK INCORPORATEDKDH2016-11-04
30884527000108ArgyleCardinal Health, Inc.KDH2016-10-14
10884527000104ArgyleCardinal Health, Inc.KDH2016-10-14
30884527000092ArgyleCardinal Health, Inc.KDH2016-10-13
20884527000095ArgyleCardinal Health, Inc.KDH2016-10-13
10889483131138Ethox MedicalETHOX MEDICAL, LLCKDH2016-09-29
10889483131145Ethox MedicalETHOX MEDICAL, LLCKDH2016-09-29
10889483150047Ethox MedicalETHOX MEDICAL, LLCKDH2016-09-29
10889483150054Ethox MedicalETHOX MEDICAL, LLCKDH2016-09-29
10889483150061Ethox MedicalETHOX MEDICAL, LLCKDH2016-09-29
20889483131135Ethox MedicalETHOX MEDICAL, LLCKDH2016-09-29