FDA.report

NOVO Health Services, LLC

Primary DI
00812564032690
Brand
NOVO Health Services, LLC
Company
NOVO HEALTH SERVICES, LLC
Model
122162
Catalog number
122162
Device description
REX MEDICINE CUP 2 OZ
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
00812564032690PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00812564032690008125640326908125640326900812564032690

GMDN Terms

TermDefinition
Medicine cup, reusableA cup specially designed for administering medicine to patients or disabled persons. It will typically be made of stainless steel or durable plastic materials and will typically have graduated markings to facilitate providing specific doses of medication. It may be used both for tablets and fluids. 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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