FDA.reportPublic FDA data

PulseSpray

Primary DI
H787123008010
Brand
PulseSpray
Company
ANGIODYNAMICS, INC.
Model
12300801
Device description
PulseSpray Injector Delivery Set
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DTLAdaptor, stopcock, manifold, fitting, cardiopulmonary bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K914987000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K914987000HIGH PRESSURE CONNECTING SETS, MODIFICATIONE-Z-Em, Inc.1992-05-20DTL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H787123008015PackageHIBCC5In Commercial Distribution
H787123008010PrimaryHIBCC0
15051684012928SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1505168401292815051684012928

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular intervention infusion catheterA flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature during a cardiovascular procedure (e.g., delivery of an antithrombotic agent); some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor superselective small vessel microcatheter. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature027 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(518)795-1676dgreer@angiodynamics.com

Regulatory Flags#

DUNS number
079105071
Device count
1
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H787140650Syntrax Support Catheter14-0652021-11-02
H787140900Syntrax Support Catheter14-0902021-11-02
H787141350Syntrax Support Catheter14-1352021-11-02
H787141500Syntrax Support Catheter14-1502021-11-02
H787141800Syntrax Support Catheter14-1802021-11-02
H787180650Syntrax Support Catheter18-0652021-11-02
H787180900Syntrax Support Catheter18-0902021-11-02
H787181350Syntrax Support Catheter18-1352021-11-02
H787181500Syntrax Support Catheter18-1502021-11-02
H787181800Syntrax Support Catheter18-1802021-12-16
H787350650Syntrax Support Catheter35-0652021-11-02
H787350900Syntrax Support Catheter35-0902021-11-02
H787351350Syntrax Support Catheter35-1352021-11-02
H787351500Syntrax Support Catheter35-1502021-11-02
H787351801Syntrax Support Catheter35-1802021-11-02
15051684018777BioFloH96544027044-0272024-09-20
15051684018784BioFloH96544028044-0282024-09-20
05051684018473LifeportH787LPS30040LPS30042026-06-23
05051684018480LifeportH787LPS30050LPS30052026-06-23
05051684018497LifeportH787LPS30060LPS30062026-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10889942000395NAMICMEDLINE INDUSTRIES, INC.DTL2026-08-18
10889942000487NAMICMEDLINE INDUSTRIES, INC.DTL2026-08-17
00884450795705Merit Medical®Merit Medical Systems, Inc.DTL2026-07-21
10193489059199NAMICMEDLINE INDUSTRIES, INC.DTL2022-08-04
10193489064520NAMICMEDLINE INDUSTRIES, INC.DTL2022-08-04
10193489059151NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-24
10193489059175NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-24
10193489064506NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-24
10193489064537NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-24
10193489059144NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-23
10193489059168NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-23
10193489059182NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-23
10193489064483NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-23
10193489064490NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-23
10193489064513NAMICMEDLINE INDUSTRIES, INC.DTL2022-02-23
10193489058819NAMICMEDLINE INDUSTRIES, INC.DTL2021-07-26
10193489058840NAMICMEDLINE INDUSTRIES, INC.DTL2021-07-26
10193489058857NAMICMEDLINE INDUSTRIES, INC.DTL2021-07-26
10193489058864NAMICMEDLINE INDUSTRIES, INC.DTL2021-07-26
10193489058871NAMICMEDLINE INDUSTRIES, INC.DTL2021-07-26
10193489058932NAMICMEDLINE INDUSTRIES, INC.DTL2021-07-26
10193489058949NAMICMEDLINE INDUSTRIES, INC.DTL2021-07-26
10193489058970NAMICMEDLINE INDUSTRIES, INC.DTL2021-07-26
H965814001240NAMICANGIODYNAMICS, INC.DTL2020-11-03
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