FDA.reportPublic FDA data

O&M Halyard, Inc.

Matched from indexed company URL: O&M HALYARD, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30144219173014421917O&M Halyard, Inc.1Y2026-01-011220 Old Alpharetta Rd Ste 320 Alpharetta GA US 30005
30145278983014527898O&M HALYARD, INC.1Y2020-04-259120 Lockwood Blvd Mechanicsville VA US 23116

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
20680651497639Halyard - HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology 24in. X 24in. (60cm X 60cm)+1(844)425-9273complaints@owens-minor.com
20680651497646Halyard - HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology 36in. X 36in. (91cm X 91cm)+1(844)425-9273complaints@owens-minor.com
20680651497653Halyard - HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology 40in. X 40in. (101cm X 101cm)+1(844)425-9273complaints@owens-minor.com
20680651497660Halyard - HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology 45in. X 45in. (114cm X 114cm)+1(844)425-9273complaints@owens-minor.com
20680651497677Halyard - HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology 48in. X 48in. (121cm X 121cm)+1(844)425-9273complaints@owens-minor.com
20680651497684Halyard - HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology 54in. X 54in. (137cm X 137cm)+1(844)425-9273complaints@owens-minor.com
30680651496936Halyard - SAFESKIN,NITRILE,EXAM GLOVE,GY,SML,200+1(844)425-9273complaints@owens-minor.com
30680651496943Halyard - SAFESKIN,NITRILE,EXAM GLOVE,GY,SML,400+1(844)425-9273complaints@owens-minor.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2182101294726534K992162SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIMLZC1999-08-30
2179801294726534K992162SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIMLZC1999-08-30
2182101144010695K992062SAFESKIN STERILE PURPLE NITRILE EXAMINATION GLOVESLZA1999-08-25
2179801144010695K992062SAFESKIN STERILE PURPLE NITRILE EXAMINATION GLOVESLZA1999-08-25
2182101132469074K984558DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE)KGO1999-02-26
2182101636309761K981393MICROCOOL SURGICAL GOWNFYA1998-07-10
2179801636309761K981393MICROCOOL SURGICAL GOWNFYA1998-07-10
2182101348970114K974068PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICALMSH1997-12-22
2179801348970114K974068PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK REGULAR SIZE, PFR95 PARTICULATE FILTER RESPIRATOR AND SURGICALMSH1997-12-22
2182101933271860K973827KIMBERLY-CLARK SELF-SEAL POUCH FOR LOW TEMPERATURE STERILIZATIONKCT1998-02-11
2179801933271860K973827KIMBERLY-CLARK SELF-SEAL POUCH FOR LOW TEMPERATURE STERILIZATIONKCT1998-02-11
2182101973206487K962188COMFIT POWDER FREE BLUE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN)LYY1996-07-26
2182101098237369K962139SAFESKINLZA1996-12-19
2179801098237369K962139SAFESKINLZA1996-12-19
2182101848356869K932834TECNOL PCM 2000FXX1994-05-03
2182102049562143K930697MEDLINE STERILE GAUZE SPONGESNAD1993-06-24
2182101265008964K926055THE MILLER NEBULIZER SYSTEMCAF1993-02-03
2182101336919336K905865ANTI-FOR SURGICAL FACE MASKFXX1991-03-06
2182101160318085K905749SURGICAL FACE MASKFXX1991-03-04
2182101445205446K902546THE PROTECTOR & HIGH PERFORMANCE SPLASH MASKFXX1990-09-05
2182101035114419K895077SURGICAL MASK/DENTAL MASKFXX1989-11-03
2182101624914805K881471KIMGUARD (REGULAR & HEAVY DUTY) STERILE WRAPFRG1988-08-10
2179801624914805K881471KIMGUARD (REGULAR & HEAVY DUTY) STERILE WRAPFRG1988-08-10
2182101217984180K880386KIMBERLY-CLARK PROTECTIVE SLEEVEFYA1988-06-23
2179801217984180K880386KIMBERLY-CLARK PROTECTIVE SLEEVEFYA1988-06-23
2182101960623381K880382KIMBERLY-CLARK IMPERVIOUS OPEN BACK GOWNFYA1988-06-23
2179801960623381K880382KIMBERLY-CLARK IMPERVIOUS OPEN BACK GOWNFYA1988-06-23
2182101961736208K874608TECNOL FLUID SHIELD SURGICAL MASKFXX1987-12-02
2182101830703812K873785TECNOL FOG-FREE SURGICAL MASK W/DERMA-TOUCH TAPEFXX1987-11-02
2182102004848570K864116ANAGO ISOLATION MASK (#80-950)LGM1986-11-25
2182101941168376K862801SPUNGUARD PLUS SURGICAL DRAPEKKX1986-08-07
2179801941168376K862801SPUNGUARD PLUS SURGICAL DRAPEKKX1986-08-07
2182101203890433K861600SPUNGUARD PLUS SURGICAL GOWNFYA1986-05-12
2179801203890433K861600SPUNGUARD PLUS SURGICAL GOWNFYA1986-05-12
2182101673682088K843260ANGIOSYS FEMORAL ANGIOGRAPHY DRAPEKKX1984-09-21
2182101737399599K842115SPUNGARD & SURG. DRAPES-GOWNS & PACKSKKX1984-06-11
2179801737399599K842115SPUNGARD & SURG. DRAPES-GOWNS & PACKSKKX1984-06-11
2182101054222930K840229CONTROL COVER GOWNFYC1984-03-19
2179801054222930K840229CONTROL COVER GOWNFYC1984-03-19
2182101661859457K832194SURGICAL FACE MASK-DISPOSABLEFXX1983-07-26
2182101127139069K831148HIGH FILTRATION ISO-MASKFXX1984-07-17
2182101855716555K823078SPUNGUARD FACE MASKFXX1983-01-07
2179801855716555K823078SPUNGUARD FACE MASKFXX1983-01-07
2182101575133027K813535XEROFORM DRESSINGFRO1982-02-04
2182101011237400K781682SURGICAL GOWNS & DRAPESFYA1978-12-20
2179801011237400K781682SURGICAL GOWNS & DRAPESFYA1978-12-20
2182101782210453K780715ANEROID TYPE BLOOD PRESSURE KITDXQ1978-07-17
2182101001206858K780169MASK, SURGICALFXX1978-02-13
2182102051846536K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesLZA2026-07-21
2182101091267294K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* TechnologyFRG2026-07-02
2182101697352478K253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization WrapFRG2026-05-18
2182101814134431K252941HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* EarloopsFXX2025-12-11
2182102064913162K251967HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops; HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops with WrapAround VisorFXX2026-03-18
2182101814527135K243604Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric AcidLZA2025-08-18
2182101171373027K243172Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile SinglesLZA2025-06-18
2182101066308593K243010Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804); Fluidshield * 3 Surgical Mask with SO SOFT* Lining (48208); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining (48207); Fluidshield * 3 Fog-Free Surgical Mask with SO SOFT* Lining, with Visor (48237); Fluidshield* 3 Fog-Free Surgical Mask with SO SOFT* Lining, Anti-Glare WrapAround Visor (48247); Fluidshield * 3 Fog-Free Procedure Mask with SO SOFT* Earloops (28797); Fluidshield * 3 Fog-Free ProceFXX2025-05-30
2182101894428426K242839Safe Secure Sterilization Pouches and RollsFRG2024-10-16
2182101504755148K241909Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric AcidLZA2024-09-27
2182101195575567K240330HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650)FRG2024-08-07
2182101806443496K240286PRIMED Surgical Masks and PRIMED Procedure MasksFXX2024-08-26
2182101189448379K234050HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization WrapFRG2024-09-16
2182101074483603K233578BAHADIR STERILIZATION CONTAINERSKCT2024-03-22
2182101666313149K233111ALGS2 Ag Alginate Wound Dressing Rx; ALGS2 Ag Alginate Wound Dressing OTC; ALGS2S Re-enforced Ag Alginate Wound Dressing Rx; ALGS2S Re-enforced Ag Alginate Wound Dressing OTCFRO2024-05-24
2182101931162626K233022Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and SmallMSH2024-01-12
2182101690890075K232894HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining (39123), HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining and Visor (39124)FXX2024-01-08
2182101142196383K232849Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)FYC2024-05-16
2182101702927418K232824FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802); FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White, Wrap Around Visor (41803); FLUIDSHIELD* 1 Surgical Mask with SO SOFT* Lining, White, (41805)FXX2024-07-02
2182101462713333K232820HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806)FXX2024-06-04
2182101642068807K232812Fluidshield* 2 Fog-Free Surgical Mask (62113); Fluidshield* 2 Fog-Free Surgical Mask with Wraparound Visor (62114); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops (62115); Fluidshield* 2 Procedure Mask with SO SOFT* Earloops and WrapAround Visor (62116)FXX2024-06-14
2182101438255923K232807Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869); Fluidshield* 1 Surgical Mask with SO SOFT* Lining (28802)FXX2024-06-21
2182101150882429K232806HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867); HALYARD* Level 1 Procedure Mask (48388)FXX2024-06-07
2182101710407125K232777FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868); FLUIDSHIELD* 1 FogFree Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender, Wrap Around Visor (41798)FXX2024-07-01
2182101360761874K232461Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Orange Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Powder Free Nitrile Examination Glove, Black Colored, Non-Sterile, Low DermatitisLZA2023-11-14
2182101010322717K231938Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING SG* SENSI-GUARD Powder-Free Nitrile Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid; Halyard STERLING NITRILE-XTRA * Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric AcidLZA2024-03-22
2182101848989374K223713Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl CitrateLZA2023-08-07
2182101645918436K220722PVC Hydrophilic Urethral CatheterEZD2023-05-22
2182101612572461K220547PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam GlovesLZA2022-06-02
2182101111265875K220541PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam GlovesLZA2022-06-02
2182101714855812K214007HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization WrapFRG2022-07-27
2182101163181012K213937Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 SolutionLZA2022-08-16
2182101145059170K213929Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric AcidLZA2022-08-01
2182102006310435K211969EMM Ultrasonic Transducer CoverITX2021-08-13
2182101824000840K211066Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3FXX2021-08-19
2182101882375084K211063HALYARD Flexaprene Green Powder-Free Exam GloveLZA2021-11-19
2182101880492853K211022Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims.LZA2021-12-22
2182101174002766K210688AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical GownFYA2021-07-21
2182101198398020K203177Sterisystem Dry-Base Instrument TrayKCT2022-01-02
2182101020855990K202622Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and and Fentanyl CitrateLZA2021-01-07
2182101237745003K201095Sovereign America Surgical Face MaskFXX2021-03-19
2182101379247208K200843Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with Chemotherapy DrugsLZA2020-09-22
2182101359720572K200633Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam GloveLZC2020-10-11
2182101423230951K200522AERO CHROME* Breathable Performance Surgical GownsFYA2020-03-16
2179801423230951K200522AERO CHROME* Breathable Performance Surgical GownsFYA2020-03-16
2182101291942247K200272Terragene ChemdyeJOJ2020-06-30
2182101497437966K200019Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black)LZA2020-04-06
2179801535258628K192362Aero Blue Performance Surgical GownsFYA2019-12-13
2182101535258628K192362Aero Blue Performance Surgical GownsFYA2019-12-13
2182101486179310K192241Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl CitrateLZA2020-03-13
2182102073414486K192147Halyard ONE-STEP* Sterilization WrapFRG2019-10-10
2179802073414486K192147Halyard ONE-STEP* Sterilization WrapFRG2019-10-10
2182101745287056K191230Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam GlovesLZC2019-11-08
2179801745287056K191230Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam GlovesLZC2019-11-08
2182101849018313K191021Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene ChemdyeFRC2019-09-13
2182101566976680K190736Disposable Powder Free Nitrile Examination Glove,Blue Color, Tested For Use With Chemotherapy DrugsLZA2019-12-23
2182101544625897K190403Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue, Tested for Use With Chemotherapy DrugsLZA2019-09-06
2182102045396772K190018Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy DrugsKGO2019-05-23
2182101503921720K183562Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy DrugsLZC2019-10-23
2182101538848408K183473AMSafe(R) Pre-Filled Normal Saline Flush SyringeNGT2019-07-12
2182101769257119K183149Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low Dermatitis and Fentanyl Permeation Resistance ClaimLZC2019-07-04
2182101513305074K183132Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy DrugsLZC2019-02-05
2179801513305074K183132Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy DrugsLZC2019-02-05
2182101796646958K182851SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy DrugsLZA2019-06-26
2179801796646958K182851SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy DrugsLZA2019-06-26
2182101749589724K182600Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)LZA2018-11-30
2179801208788775K182096Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy DrugsLZA2018-11-02
2182101208788775K182096Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy DrugsLZA2018-11-02
2182101203908075K181959HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)FRG2019-03-22
2179801203908075K181959HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)FRG2019-03-22
2182101486769167K181887AMD Anti-Fog SolutionOCT2019-01-22

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LZA622026-07-21
FRG412026-07-02
FXX362026-03-18
FYA312021-07-21
LZC212020-10-11
KKX132010-11-09
KGO92019-05-23
LYZ72011-10-27
KCT52024-03-22
LYY52012-05-14
FYC42024-05-16
MSH42024-01-12
OXZ42012-05-04
DWJ42003-11-12
FRO22024-05-24
EZD22023-05-22
FRC22019-09-13
KNT22016-06-21
ITX12021-08-13
JOJ12020-06-30
NGT12019-07-12
OCT12019-01-22
FLL12017-09-19
MPN12015-10-26
PIF12014-10-16
KMJ12012-04-10
GEI12010-11-03
DRX12010-05-10
HIB12010-02-16
FMF12006-06-29
IOR12005-10-05
MPO12004-05-03
CAH12003-07-07
FCM12003-05-23
NAD11993-06-24
CAF11993-02-03
LGM11986-11-25
DXQ11978-07-17

NDC#

PMN#

GUDID#

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