FDA.report

Halyard

Primary DI
30680651446641
Brand
Halyard
Company
O&M HALYARD, INC.
Model
44664
Catalog number
44664NS
Device description
AERO CHROME* Breathable Performance Surgical Gown, XL
Published
2019-10-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FYAGOWN, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
FYAGown, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30680651446641PrimaryGS10
90680651446643Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3068065144664130680651446641
9068065144664390680651446643

GMDN Terms

TermDefinition
Surgical gown, single-useA garment made of natural and/or synthetic materials intended to be worn over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure; it may be fluid resistant or impervious to fluids. Also known as an operating room (OR) gown, it is used during surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a single-use garment.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(844)425-9273PIQ@hyh.com

Regulatory Flags

DUNS number
081057389
Device count
32
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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30680651335006Halyard33500335002020-11-16
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90680651337248Halyard33724337242020-11-16
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30680651493652Halyard49365493652025-09-23
30680651493409Halyard49340493402025-09-19
30680651493423Halyard49342493422025-09-19

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