Ev1000

FDA UDI

Class II (US FDA UDI)

by Edwards Lifesciences LLC

Identity

Trade Name: EV1000 FDA UDI
Generic Name: Cable/lead/sensor/probe cover, sterile FDA UDI
Device Name: PRESSURE CONTROLLER CUFF CONNECTOR CAP FDA UDI
Model / Reference: PC2CCC FDA UDI
Description: PRESSURE CONTROLLER CUFF CONNECTOR CAP FDA UDI

Identifiers

Catalog Number: PC2CCC FDA UDI
Primary DI / UDI-DI: 00690103193626 FDA UDI
510(k) Number: K140312 FDA UDI
K160552 FDA UDI
FDA Product Code: DSB FDA UDI
DXN FDA UDI
GMDN Term: Cable/lead/sensor/probe cover, sterile FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2770 FDA UDI
870.1130 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

FDA UDI

Manufacturing Date

FDA UDI

Category: Cable/lead/sensor/probe cover, sterile

Ev1000 by Edwards Lifesciences LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cable/lead/sensor/probe cover, sterile.

Sterimed — Sterimed, Inc. · Class II
Sterimed — Sterimed, Inc. · Class II
DEXcam3™ intra-oral camera sheaths — DEXIS LLC · Class I
Hygienic Sleeves 3D Bite Block — Carestream Dental LLC · Class I
Probe Cover Kits — PROTEK MEDICAL PRODUCTS, INC. · Class II
Hygienic Sleeves Bite Block — CARESTREAM HEALTH, INC. · Class I
CS 7600 Hygienic Sheath — CARESTREAM HEALTH, INC. · Class I
DEXcam4™ Intra-oral camera sheaths — DEXIS LLC · Class I

Cleared under the same submission

K140312 also covers:

K160552 also covers:

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 a4d29507-3a32-44ef-90a3-190240701ca2 38 fields · synced Jun 6, 2026