FDA.reportPublic FDA data

Axiom® CWV

Primary DI
M66536433
Brand
Axiom® CWV
Company
AXIOM MEDICAL, INCORPORATED
Model
3643
Device description
Closed Wound Drain, Round, Silicone
Published
2018-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K790654000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K790654000CLOSED WOUND VACUUM DRAINAGE SYSTEM3M Company1979-04-26GCY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M66536431PackageHIBCC10In Commercial Distribution
M66536433PackageHIBCC10In Commercial Distribution
M66536430PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Closed-wound drain, non-bioabsorbableA tube-like, non-bioabsorbable device designed to establish a channel for the removal of fluid or purulent material from a closed-wound or an infected area, typically used with a closed drainage system that applies a low negative pressure through the drain lumen. It is typically made of silicone and comes in various designs/sizes for a variety of surgical applications (e.g., orthopaedic, plastic/reconstructive, neurological, gynaecological, thoracic, cardiovascular, general surgery). It might include disposable devices dedicated to drain insertion/function (e.g., sharp trocar blade, connector), however it does not include any fluid collection bags/containers. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
094439676
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
false
Expiration date on label
true
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
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
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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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