FDA.reportPublic FDA data

Halyard

Primary DI
10809160323496
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
RM2025A_0006
Catalog number
RM2025A
Published
2020-12-11
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
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
K854816000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K854816000EPIDURAL ANESTHESIA NEEDLESReganes, Inc.1985-12-19BSP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160323493PackageGS110In Commercial Distribution
10809160323496PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916032349320809160323493
1080916032349610809160323496

GMDN Terms#

Term, Definition table
TermDefinition
Epidural needle, non-threadedA sterile, sharp bevel-edged, hollow tubular metal instrument designed to access the epidural space. It may be used to deliver anaesthetic or analgesic agents or to introduce a dedicated catheter for continuous anaesthesia administration. If used with a stylet, it is often referred to as a cannula. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(888) 564-7153PIQ@owens-minor.com

Regulatory Flags#

DUNS number
015623119
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160539002HalyardMAMC223-14_0003MAMC223-142026-09-25
10809160539040HalyardEURO005-09_0005EURO005-092026-09-25
10809160539057HalyardEURO003-10_0005EURO003-102026-09-25
10809160539064HalyardEURO003-11_0002EURO003-112026-09-25
10809160539071HalyardEURO005-10_0002EURO005-102026-09-25
10809160539088HalyardEURO006-10_0002EURO006-102026-09-25
10809160539095HalyardEURO006-09_0001EURO006-092026-09-25
10809160539101HalyardHVBM205-04_0005HVBM205-042026-09-25
10809160539118HalyardWINN117-05_0014WINN117-052026-09-25
10809160538920HALYARDBPEN95-02BPEN95-022026-09-24
10809160538944HalyardMAMC221-16_0031MAMC221-162026-09-24
10809160538951HalyardJACK410-11_0008JACK410-112026-09-24
10809160538975HalyardWBAM044-04_0003WBAM044-042026-09-24
10809160538982HalyardSWMR007-04_0008SWMR007-042026-09-24
10809160538586HalyardGBDV49-02_0011GBDV49-022026-09-22
10809160538593HalyardBPTJ33-02_0019BPTJ33-022026-09-22
10809160538616HalyardHVBM201-06_0005HVBM201-062026-09-22
10809160538623HalyardSAMM018-14_0005SAMM018-142026-09-22
10809160538630HalyardLVMN12-02_0009LVMN12-022026-09-22
10809160538647HalyardWRNM015-12_0006WRNM015-122026-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048223134030SonoPlex® II SuperCutPajunk GmbH MedizintechnologieBSP2026-08-27
04048223134054SonoPlex® II SuperCutPajunk GmbH MedizintechnologieBSP2026-08-27
04048223134078SonoPlex® II SuperCutPajunk GmbH MedizintechnologieBSP2026-08-27
04048223134092SonoPlex® II SuperCutPajunk GmbH MedizintechnologieBSP2026-08-27
04048223139110CauDal SonoPajunk GmbH MedizintechnologieBSP2026-07-06
04048223070499NerveGuard NRFitPajunk GmbH MedizintechnologieBSP2026-06-10
04048223076217Quincke NRFitPajunk GmbH MedizintechnologieBSP2026-06-10
04048223076248Quincke NRFitPajunk GmbH MedizintechnologieBSP2026-06-10
04048223076347Quincke NRFitPajunk GmbH MedizintechnologieBSP2026-06-10
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
05060498301626Dash 6GBUK GROUP LIMITEDBSP2023-06-02
05060498301657Dash 6GBUK GROUP LIMITEDBSP2023-06-02
05060498301770Dash 6GBUK GROUP LIMITEDBSP2023-06-02
05060498306898Dash 6GBUK GROUP LIMITEDBSP2023-06-02
05060498306928Dash 6GBUK GROUP LIMITEDBSP2023-06-02
05060498307345Dash 6 NRFit™GBUK GROUP LIMITEDBSP2023-06-02