FDA.report

Micro In-Line Dual DISS Outlet Kit, NS

Primary DI
00813830021776
Brand
Micro In-Line Dual DISS Outlet Kit, NS
Company
ACCUTRON, INC.
Model
34013-3-NS
Catalog number
34013-3-NS
Published
2016-09-27
Public version status
Update
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
BXHGauge, Gas Pressure, Cylinder/Pipeline
BYXTubing, Pressure And Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
BXHGauge, Gas Pressure, Cylinder/PipelineAnesthesiology1
BYXTubing, Pressure And AccessoriesAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00813830021776PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00813830021776008138300217768138300217760813830021776

GMDN Terms

TermDefinition
Medical gas pipeline systemAn assembly of devices designed to supply compressed medical gases [e.g., oxygen (O2), nitrous oxide (N2O), medical air, surgical-grade air] from a central source to endpoints throughout a medical facility. The system typically consists of several gas supplies (bulk gas, bottled gas with air compressors), a pipework system that includes pressure regulators, pressure relief valves, zone valves, an alarm system with remote or local indicators, emergency backup devices for essential gases, and wall outlet/inlet terminal units.

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-483-7433regulatoryaffairs@hu-friedy.com

Regulatory Flags

DUNS number
088302096
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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