FDA.report

NOVO Health Services, LLC

Primary DI
00812564032812
Brand
NOVO Health Services, LLC
Company
NOVO HEALTH SERVICES, LLC
Model
123122
Catalog number
123122
Device description
EYE BOWL, 900CC
Published
2018-09-24
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FNYBasin, Emesis

Product Code Classifications

CodeDeviceSpecialtyClass
FNYBasin, EmesisGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00812564032812PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00812564032812008125640328128125640328120812564032812

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.

Device Sizes

TypeValueUnit
Height3Inch

Sterilization Methods

Method

Contacts

PhoneEmail
8138919550customerservice@novohealthservices.com

Regulatory Flags

DUNS number
069936106
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
true
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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