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BladeClear

FDA UDI

Class I (US FDA UDI)

by Pathway Medtech, Llc.

Identity

Trade Name
BladeClear FDA UDI
Generic Name
Luminal device flushing tubing set, single-use FDA UDI
Device Name
BladeClear Small Shaver Accessory FDA UDI
Model / Reference
BCS-01 FDA UDI
Description
BladeClear Small Shaver Accessory FDA UDI

Identifiers

Catalog Number
BCS-01 FDA UDI
Primary DI / UDI-DI
00860012804412 FDA UDI
FDA Product Code
KGZ FDA UDI
GMDN Term
Luminal device flushing tubing set, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4200 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Luminal device flushing tubing set, single-use

BladeClear by Pathway Medtech, Llc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Luminal device flushing tubing set, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Pathway Medtech, Llc.

Sources (1)

  • FDA UDI 91da8c69-c482-4796-b073-caf098966945 34 fields · synced May 30, 2026