Vamp

FDA UDI

Class II (US FDA UDI)

by Edwards Lifesciences LLC

Identity

Trade Name: VAMP FDA UDI
Generic Name: Arterial blood sampling kit FDA UDI
Device Name: PRESSURE MONITORING ACCESSORY FDA UDI
Model / Reference: VMP400 FDA UDI
Description: PRESSURE MONITORING ACCESSORY FDA UDI

Identifiers

Catalog Number: VMP400 FDA UDI
Primary DI / UDI-DI: 07460691949874 FDA UDI
510(k) Number: K896819 FDA UDI
FDA Product Code: KRA FDA UDI
GMDN Term: Arterial blood sampling kit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1210 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Arterial blood sampling kit

Vamp by Edwards Lifesciences LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Arterial blood sampling kit.

Portex — ICU MEDICAL, INC. · Class II
AirLife™ — Airlife, Inc. · Class I
Portex — ICU MEDICAL, INC. · Class II
Portex — ICU MEDICAL, INC. · Class II
MEDLINE — MEDLINE INDUSTRIES, INC. · Class I
Portex — ICU MEDICAL, INC. · Class II
Portex — ICU MEDICAL, INC. · Class II
Atellica® VTR Syringes — WESTMED, INC. · Class I

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Edwards Lifesciences LLC

Sources (1)

FDA UDI b8046938-8ea2-404f-8e5b-eacc0b9ce99f 38 fields · synced Jun 8, 2026