FDA.reportPublic FDA data

Halyard

Primary DI
10680651135398
Brand
Halyard
Company
Avanos Medical, Inc.
Model
13539
Catalog number
PM040-A
Device description
HALYARD* ON-Q* Catheters-SilverSoaker* 10 In. (25cm)
Published
2016-08-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BSOCATHETER, CONDUCTION, ANESTHETIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSOCatheter, Conduction, AnestheticAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051401000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051401000ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW CATHETERI-Flow Corp.2005-11-30BSO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30680651135392PackageGS15In Commercial Distribution
10680651135398PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3068065113539230680651135392
1068065113539810680651135398

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia conduction catheter, antimicrobialA sterile, flexible tube intended to be percutaneously introduced for the repeated or continuous injection of local anaesthetics for preoperative, intraoperative, or postoperative regional anaesthesia and/or pain management; it may be placed in the epidural space, into or around surgical wound sites, or near peripheral nerves. It is coated with an antimicrobial agent to help prevent infection and may include devices dedicated to catheter introduction/function (e.g., needle, sheath). This device is typically used during surgical or diagnostic procedures or for the temporary relief of chronic pain in the limbs, pelvis, abdomen, or lumbar spine. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(844)425-9273xxx@xxx.xxx

Regulatory Flags#

DUNS number
079375431
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10680651458350Halyard4583525-0082017-09-18
10680651458367Halyard4583625-0102017-09-18
10680651458374Halyard4583725-0122017-09-18
10680651469035Halyard4690325-0142017-09-18
10680651469042Halyard4690425-0162017-09-18
10680651469059Halyard4690525-0182017-09-18
00193494135263AVANOS*500108750010872020-09-25
10680651124767COOLIEF* Cooled Radiofrequency QUICKCLAMP* Device12476SIA-QC2016-05-17
00812120005083Game Ready* 6' Dual Connector Hose, Rental120004997570302-RN2026-04-24
00812120005090Game Ready* 6' Medical Connector Hose, Rental120004999570304-RN2026-04-24
00812120005106Game Ready* Wrap Extender Strap Kit, Rental120004998573226-RN2026-04-17
00609038351117AVANOS35111351112020-04-01
00609038351124AVANOS35112351122020-04-01
00609038351131AVANOS35113351132020-04-01
00609038351148AVANOS35114351142020-04-01
00609038351155AVANOS35115351152020-04-01
00609038351162AVANOS35116351162020-04-01
00609038351179AVANOS35117351172020-04-01
00609038351186AVANOS35118351182020-04-01
00609038351193AVANOS35119351192020-04-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10801902197631ARROWTELEFLEX INCORPORATEDBSO2022-11-09
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10801902200614ARROWTELEFLEX INCORPORATEDBSO2022-11-09
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10801902207507ARROWTELEFLEX INCORPORATEDBSO2022-05-13
10801902207835ARROWTELEFLEX INCORPORATEDBSO2022-05-11
10801902207569ARROWTELEFLEX INCORPORATEDBSO2022-04-29
10801902207682ARROWTELEFLEX INCORPORATEDBSO2022-04-29
10801902207743ARROWTELEFLEX INCORPORATEDBSO2022-04-29
10801902207842ARROWTELEFLEX INCORPORATEDBSO2022-04-29
10801902207446ARROWTELEFLEX INCORPORATEDBSO2022-04-11
10801902207668ARROWTELEFLEX INCORPORATEDBSO2022-04-11
10801902207736ARROWTELEFLEX INCORPORATEDBSO2022-04-11