O&M HALYARD, INC.

Address:1 Edison Drive,Alpharetta,GA,30005,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Drape, surgical (KKX) (4) Respirator, surgical (MSH) (3) GOWN, SURGICAL (FYA) (2) Drape, surgical, exempt (PUI) (1)

Premarket Exempt

No Yes

Clear

Halyard - 30680651798351 Catalog Number :

Device Description : SURGICAL DRAPE 14

Device Class :

Duns Number: 081057389

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 14

Halyard - 30680651798610 Catalog Number :

Device Description : HYH OEM STOCKINETTE

Device Class :

Duns Number: 081057389

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 90

Halyard - 30680651798818 Catalog Number :

Device Description : HYH OEM STOCKINETTE LGE

Device Class :

Duns Number: 081057389

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 56

Halyard - 30680651799457 Catalog Number : 79945

Device Description : International Diathermy Pouch 16 in. x 15 in. / 41 cm x 38 cm

Device Class :

Duns Number: 081057389

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 220

Halyard - 30680651799709 Catalog Number :

Device Description : STANDARD GOWN LARGE 44

Device Class :

Duns Number: 081057389

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 40

Halyard - 30680651863073 Catalog Number : 86307

Device Description : Impervious Split Drape

Device Class :

Duns Number: 081057389

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1120

Halyard - 30680651915123 Catalog Number :

Device Description : SURGICAL REINFORCED GOWN LARGE 40

Device Class :

Duns Number: 081057389

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 40

Halyard - 30680651991752 Catalog Number : 99175

Device Description : Fluidshield* 3 Ported N95 Particulate Filter Respirator with SO SOFT* Lining, Or Fluidshield* 3 Ported N95 Particulate Filter Respirator with SO SOFT* Lining, Orange, Regular Size

Device Class : 2

Duns Number: 081057389

Premarket Exempt : No

Product Code : MSH

Prescription Use : No

Device Count : 100

Halyard - 30680651991813 Catalog Number : 99181

Device Description : FLUIDSHIELD* 3 Ported N95 Particulate Filter Respirator with SO SOFT* Lining, Or FLUIDSHIELD* 3 Ported N95 Particulate Filter Respirator with SO SOFT* Lining, Orange, Small Size

Device Class : 2

Duns Number: 081057389

Premarket Exempt : No

Product Code : MSH

Prescription Use : No

Device Count : 100

Halyard - 30680651991844 Catalog Number : 99184

Device Description : FLUIDSHIELD* 3 Ported N95 Particulate Filter Respirator with SAFETY SEAL and SO FLUIDSHIELD* 3 Ported N95 Particulate Filter Respirator with SAFETY SEAL and SO SOFT* Lining, Orange, Small Size

Device Class : 2

Duns Number: 081057389

Premarket Exempt : No

Product Code : MSH

Prescription Use : No

Device Count : 100

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