Aquastat

FDA UDI

Class II (US FDA UDI)

by Mrp, Llc

Identity

Trade Name: Aquastat FDA UDI
Generic Name: Vascular catheter flush syringe FDA UDI
Device Name: Pre-filled Flush Syringe with 0.9% NaCL (saline), 3mL, Sterile Fluid FDA UDI
Model / Reference: 2T0807 FDA UDI
Description: Pre-filled Flush Syringe with 0.9% NaCL (saline), 3mL, Sterile Fluid FDA UDI

Identifiers

Catalog Number: 2T0807 FDA UDI
Primary DI / UDI-DI: 10859809005030 FDA UDI
510(k) Number: K111034 FDA UDI
FDA Product Code: NGT FDA UDI
GMDN Term: Vascular catheter flush syringe 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

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

FDA UDI

Dimensions & Sizes

Size: Total Volume — 3 Milliliter FDA UDI

Category: Vascular catheter flush syringe

Aquastat by Mrp, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K111034 also covers:

Aquastat — MRP, LLC
Aquastat — MRP, LLC

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

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Manufacturer

Manufacturer: Mrp, Llc

Sources (1)

FDA UDI 42c80a3f-43b4-4937-9f75-18b0bdec0c9e 38 fields · synced May 29, 2026