Halyard

Primary DI
10680651467314
Brand
Halyard
Company
Avanos Medical, Inc.
Model
46731
Catalog number
N589A001
Device description
N589A001 HYH,LORSYR,LOSSYR,-,-,25
Published
2017-12-21
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
FMFSyringe, piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K941562000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K9415620001ML LUER-LOK SYRINGEBd Becton Dickinson Vacutainer Systems Preanalytic1994-05-26FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30680651467318PackageGS125Not in Commercial Distribution
10680651467314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3068065146731830680651467318
1068065146731410680651467314

GMDN Terms#

Term, Definition table
TermDefinition
Manual epidural space locatorA device intended to be inserted between a syringe and an epidural needle to provide visual confirmation of needle insertion within the epidural space (location confirmation). It is typically a small chamber with a one-way valve and an expandable membrane (diaphragm), and Luer inlet and exit ports. The diaphragm is inflated with air prior to insertion; diaphragm collapse signals entry into the epidural space. 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
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
10680651467185Halyard46718N589132017-12-21
10680651467192Halyard46719N589072017-12-21
10680651467208Halyard46720N589082017-12-21
10680651985863Halyard98586189A0002016-01-31
10680651985870Halyard98587189A0012016-01-31
10680651985900Halyard98590189A0092016-01-31
00193493924097AVANOS92409189072019-09-25
00193493924110AVANOS92411189132019-09-25
00350770005881CORTRAK* 2 Enteral Access System120002806P20-09502026-09-30
00350770007915CORTRAK* 2 Enteral Access System12000858320-09502026-09-30
10680651135718Halyard13571PM0062016-08-10
10680651136128Halyard13612PM0022016-08-10
10680651136135Halyard13613PM0032016-08-10
10680651136142Halyard13614PM0042016-08-10
10680651136159Halyard13615PM0052016-08-10
00193494135713ON-Q* Pain Relief System13571PM0062020-05-07
00193494136123ON-Q* Pain Relief System13612PM0022020-05-07
00193494136130ON-Q* Pain Relief System13613PM0032020-05-07
00193494136147ON-Q* Pain Relief System13614PM0042020-05-07
00193494136154ON-Q* Pain Relief System13615PM0052020-05-07

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Primary DI, Brand, Company table
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20612479288526McKessonMCKESSON MEDICAL-SURGICAL INC.FMF2026-10-08
10304040193843Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193850Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
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10304040193874Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
10304040193881Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
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10304040194314Henry ScheinHENRY SCHEIN, INC.FMF2026-10-05
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