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Hcs

FDA UDI

Class II (US FDA UDI)

by Dyad Medical Sourcing, Llc

Identity

Trade Name
HCS FDA UDI
Generic Name
Peripheral intravenous catheterization kit, non-sensing FDA UDI
Device Name
PICC Line Advanced with Statlock Kit FDA UDI
Model / Reference
HCS0008D FDA UDI
Description
PICC Line Advanced with Statlock Kit FDA UDI

Identifiers

Primary DI / UDI-DI
00849027005168 FDA UDI
FDA Product Code
OWL FDA UDI
GMDN Term
Peripheral intravenous catheterization kit, non-sensing FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5200 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

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Category: Peripheral intravenous catheterization kit, non-sensing

Hcs by Dyad Medical Sourcing, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Peripheral intravenous catheterization kit, non-sensing.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dyad Medical Sourcing, Llc

Sources (1)

  • FDA UDI 11747549-644f-4f79-b91b-163699415493 33 fields · synced Jun 8, 2026