← Back to catalogue

PreciseDose Dispenser

FDA UDI

Class I (US FDA UDI)

by Medisca Inc.

Identity

Trade Name
PreciseDose Dispenser FDA UDI
Generic Name
Oral/enteral medicine medicated administration kit, reusable FDA UDI
Device Name
Syringe, PreciseDose Dispenser Clear, 0.5mL, w/Tip cap FDA UDI
Model / Reference
8155-01 FDA UDI
Description
Syringe, PreciseDose Dispenser Clear, 0.5mL, w/Tip cap FDA UDI

Identifiers

Catalog Number
8155-01 FDA UDI
Primary DI / UDI-DI
00338779815519 FDA UDI
FDA Product Code
KYX FDA UDI
GMDN Term
Oral/enteral medicine medicated administration kit, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6430 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Oral/enteral medicine medicated administration kit, reusable

PreciseDose Dispenser by Medisca Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Oral/enteral medicine medicated administration kit, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Medisca Inc.

Sources (1)

  • FDA UDI 0fae0617-b746-43f7-9eee-c0aa8c2b3413 34 fields · synced Jun 8, 2026