FDA.reportPublic FDA data

Easy Spray

Primary DI
05413760499055
Brand
Easy Spray
Company
BAXTER HEALTHCARE CORPORATION
Model
1504719
Catalog number
1504719
Device description
Easy Spray Pressure Regulator
Published
2016-10-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CANRegulator, pressure, gas cylinder
FMFSyringe, piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CANRegulator, Pressure, Gas CylinderAnesthesiology1
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K050495000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K050495000EASYSPRAY AND SPRAY SET FOR TISSEEL (FIBER SEALANT)Baxter Healthcare Corp., Bioscience2005-05-02FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05413760499055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05413760499055054137604990555413760499055

GMDN Terms#

Term, Definition table
TermDefinition
Medical device air compressorA mains electricity (AC-powered) device designed to create compressed air and supply it directly to gas-powered or compressed air dependent devices (e.g., ventilators or other respiratory devices, laboratory equipment). It may also provide medical air depending upon the filtering systems employed.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Protect from heat and radioactive sources.
Storage Environment Humidity10 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)933-0303Medinfo_medproducts@baxter.com

Regulatory Flags#

DUNS number
005083209
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00085412000046INTRAVIA2B80142B80142016-09-24
00085412003191INTRAVIA2B80122B80122016-09-24
00085412003467INTRAVIA2B80112B80112016-09-24
00085412003504INTRAVIA2B80192B80192016-09-24
00085412029566INTRAVIA2J80032J80032016-09-24
00085412029573INTRAVIA2J80022J80022016-09-24
00085412035260INTRAVIA2B80132B80132016-09-24
00085412048475CLEARLINK/DUO-VENT2C74622C74622016-09-24
00085412079677CLEARLINK/CONTINU-FLOACT8570ACT85702016-09-24
00085412046327CLEARLINK/CONTINU-FLO2C85712C85712016-09-24
00085412048451CLEARLINK/CONTINU-FLO2H85192H85192016-09-24
00085412080901CLEARLINK/CONTINU-FLO2H85372H85372016-09-24
00085412676630DUO-VENT2R84042R84042023-07-11
00085412478296BaxterH93813501H938135012026-05-29
00085412478302BaxterH93813601H938136012026-05-29
00085412004945INTERLINK2N33792N33792016-09-24
00085412004983INTERLINK2N33992N33992016-09-24
00085412048895CLEARLINK2N83992N83992016-09-24
00085412002125INTERLINK2C64022C64022016-09-24
00085412003948INTERLINK/DUO-VENT2C64192C64192016-09-24

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