FDA.report

Hayden Medical

Primary DI
00840319717622
Brand
Hayden Medical
Company
Hayden Medical, Inc.
Model
PWE08
Catalog number
PWE08
Device description
Emesis Basin 12oz. (8-1/8"L x 3-5/8"W x 1-5/8"H), stainless steel
Published
2022-08-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FNYBASIN, EMESIS

Product Code Classifications

CodeDeviceSpecialtyClass
FNYBasin, EmesisGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840319717622PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840319717622008403197176228403197176220840319717622

GMDN Terms

TermDefinition
Emesis bowl, reusableA device designed as a receptacle for vomit or oral secretions, typically from an immobile patient (e.g., one confined to bed, chair, or wheelchair). It is typically shallow and kidney-shaped, and therefore commonly known as a kidney bowl or basin. It is typically made of high-grade stainless steel or durable plastic materials, and is also commonly used to hold and transport medical/surgical materials or instruments for a procedure. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(661)296-7200info@haydenmedical.com

Regulatory Flags

DUNS number
618214410
Device count
1
DM exempt
false
Premarket exempt
true
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
true

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00840319758410Hayden MedicalE3-2718E3-27182025-12-24
00840319758496Hayden Medical105-122XT105-122XT2025-12-24
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