FDA.reportPublic FDA data

Halyard

Primary DI
30680651414817
Brand
Halyard
Company
Avanos Medical, Inc.
Model
41481
Catalog number
188A09
Device description
CATHK1,CATHST,-,-,10
Published
2016-09-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BSPNEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K000495000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000495000BALLARD MEDICAL PRODUCTS EPIDURAL AND SPINAL NEEDLESBallard Medical Products2000-03-28BSP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30680651414817PackageGS110Not in Commercial Distribution
10680651414813PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3068065141481730680651414817
1068065141481310680651414813

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral anaesthesia catheter set, non-medicatedA collection of devices intended for the continuous-administration of an anaesthetic agent (not included) to function as a peripheral nerve-block. It includes an anaesthesia needle and an anaesthesia catheter usually with additional devices utilized for the procedure (e.g., connectors, catheter holder). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
079375431
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198459468025MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.BSP2025-08-18
M661S103417350Plastic BD Style Hub Tuohy Epidural NeedleSpectra Medical Devices, LLCBSP2024-06-18
M661S103418350Plastic BD Style Hub Tuohy Epidural NeedleSpectra Medical Devices, LLCBSP2024-06-18
M661S103418500Plastic BD Style Hub Tuohy Epidural NeedleSpectra Medical Devices, LLCBSP2024-06-18
M661S80C21600MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-06-18
M661S80C22200MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-06-18
M661S80C23200MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-06-18
M661S90C22600MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-06-18
08886479300252Reach NeedleAerin Medical Inc.BSP2024-06-10
M661S80C21200MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-02-12
M661S80C21400MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-02-12
00382904003715BD Whitacre SpinalBECTON, DICKINSON AND COMPANYBSP2023-09-02
00382904003722BD Whitacre SpinalBECTON, DICKINSON AND COMPANYBSP2023-09-02
00382904003739BD Whitacre SpinalBECTON, DICKINSON AND COMPANYBSP2023-09-02
00382904003821BD Whitacre SpinalBECTON, DICKINSON AND COMPANYBSP2023-09-02
10193489250428Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BSP2022-08-04
10193489250510Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BSP2022-08-04
10193489778083Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BSP2022-08-04
10193489902822Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BSP2022-08-04
10612479261003McKessonMCKESSON MEDICAL-SURGICAL INC.BSP2022-07-19
10612479261034McKessonMCKESSON MEDICAL-SURGICAL INC.BSP2022-07-19
10612479261065McKessonMCKESSON MEDICAL-SURGICAL INC.BSP2022-07-19
10612479261096McKessonMCKESSON MEDICAL-SURGICAL INC.BSP2022-07-19
10612479261126McKessonMCKESSON MEDICAL-SURGICAL INC.BSP2022-07-19
10612479261157McKessonMCKESSON MEDICAL-SURGICAL INC.BSP2022-07-19
10193489253023Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BSP2021-08-27
10193489550115MedlineMEDLINE INDUSTRIES, INC.BSP2021-01-28
10193489270990MedlineMEDLINE INDUSTRIES, INC.BSP2021-01-27
10680651479096HalyardAvanos Medical, Inc.BSP2019-07-15
10680651477566HalyardAvanos Medical, Inc.BSP2019-06-15