Clearsight

FDA UDI

Class II (US FDA UDI)

by Edwards Lifesciences LLC

Identity

Trade Name: CLEARSIGHT FDA UDI
Generic Name: Blood pressure cuff, single-use FDA UDI
Device Name: CLEARSIGHT FINGER CUFF MEDIUM MULTI PACK FDA UDI
Model / Reference: CSCM FDA UDI
Description: CLEARSIGHT FINGER CUFF MEDIUM MULTI PACK FDA UDI

Identifiers

Catalog Number: CSCM FDA UDI
Primary DI / UDI-DI: 00690103193350 FDA UDI
510(k) Number: K140312 FDA UDI
K160552 FDA UDI
FDA Product Code: DXN FDA UDI
DSB FDA UDI
GMDN Term: Blood pressure cuff, single-use FDA UDI

Classification

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

Clinical & Handling

Sterile

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

MRI Safety

MR Unsafe FDA UDI

Category: Blood pressure cuff, single-use

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

Similar devices

Also classified as Blood pressure cuff, single-use.

Unimed — Unimed Medical Supplies, Inc. · Class II
Unimed — Unimed Medical Supplies, Inc. · Class II
Orantech — Orantech Inc. · Class II
Statcorp Medical — STATCORP MEDICAL · Class II
Medline — MEDLINE INDUSTRIES, INC. · Class II
Softcheck — STATCORP MEDICAL · Class II
Regard™ — RESOURCE OPTIMIZATION & INNOVATION, L.L.C. · Class II
MEDLINE INDUSTRIES, INC. — MEDLINE INDUSTRIES, INC. · Class II

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 5f19105c-071d-49fa-9e23-ebee23617154 38 fields · synced Jun 8, 2026