FDA.report

MEDICAL ACTION INDUSTRIES

Primary DI
20809160246723
Brand
MEDICAL ACTION INDUSTRIES
Company
MEDICAL ACTION INDUSTRIES INC.
Model
79619
Published
2019-07-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
OGWTracheostomy kit

Product Code Classifications

CodeDeviceSpecialtyClass
OGWTracheostomy KitAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20809160246723PackageGS120Not in Commercial Distribution
10809160246726PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2080916024672320809160246723
1080916024672610809160246726

GMDN Terms

TermDefinition
Tracheostomy kit, single-useA collection of sterile surgical instruments, dressings/swabs, syringe, dilators, tracheostomy tubes and other items intended to be used to create a percutaneous opening in the trachea (tracheotomy) for the insertion of a tracheostomy tube to relieve upper airway obstruction and to facilitate ventilation. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00STORE AT ROOM TEMPERATURE

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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