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PulseSpray

FDA UDI

Class II (US FDA UDI)

by Angiodynamics, Inc.

Identity

Trade Name
PulseSpray FDA UDI
Generic Name
Peripheral vascular intervention infusion catheter FDA UDI
Device Name
PulseSpray Infusion System FDA UDI
Model / Reference
12500422 FDA UDI
Description
PulseSpray Infusion System FDA UDI

Identifiers

Primary DI / UDI-DI
H787125004220 FDA UDI
510(k) Number
K163356 FDA UDI
FDA Product Code
KRA FDA UDI
GMDN Term
Peripheral vascular intervention infusion catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1210 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 135 Centimeter FDA UDI
Catheter Gauge — 3 French FDA UDI

PulseSpray by Angiodynamics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K163356 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Angiodynamics, Inc.

Sources (1)

  • FDA UDI b549e5fe-6771-4a1f-b189-48f152b63374 37 fields · synced Jun 8, 2026