FDA.report

MEDICAL ACTION INDUSTRIES

Primary DI
20809160107253
Brand
MEDICAL ACTION INDUSTRIES
Company
MEDICAL ACTION INDUSTRIES INC.
Model
75865
Published
2016-09-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
NSBPatient personal hygiene kit

Product Code Classifications

CodeDeviceSpecialtyClass
NSBPatient Personal Hygiene KitDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20809160107253PackageGS18Not in Commercial Distribution
10809160107256PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2080916010725320809160107253
1080916010725610809160107256

GMDN Terms

TermDefinition
Personal care kitA collection of devices intended to be used by a patient for personal care needs during a stay in a healthcare institution. It typically contains items such as gown, slippers, cap, hair comb and toothbrush in a storage bag, and may also contain additional personal care products e.g., toothpaste, lotion and deodorant. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00

Sterilization Methods

Method

Regulatory Flags

DUNS number
092364462
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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