crn CRONO Syringe reservoir

FDA UDI

Class II (US FDA UDI)

by Cane' Spa

Identity

Trade Name: crn CRONO Syringe reservoir FDA UDI
Generic Name: General-purpose syringe, single-use FDA UDI
Device Name: 50 ml reservoir for CRONO ambulatory syringe infusion pumps FDA UDI
Model / Reference: CRN50ML FDA UDI
Description: 50 ml reservoir for CRONO ambulatory syringe infusion pumps FDA UDI

Identifiers

Primary DI / UDI-DI: 08050616611550 FDA UDI
510(k) Number: K041414 FDA UDI
FDA Product Code: FRN FDA UDI
GMDN Term: General-purpose syringe, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5725 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 — 50 Milliliter FDA UDI

Category: General-purpose syringe, single-use

crn CRONO Syringe reservoir by Cane' Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose syringe, single-use.

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SOFT-JECT® — Henke-Sass, Wolf GmbH · Class II
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SURGYCO — Surgyco LLC · Class I
NAMIC — MEDLINE INDUSTRIES, INC. · Class II
HSW HENKE-JECT® — Henke-Sass, Wolf GmbH · Class II
BD Safety-Lok — BECTON DICKINSON AND COMPANY · Class II
SURGYCO — Surgyco LLC · Class I

Cleared under the same submission

K041414 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

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Manufacturer

Manufacturer: Cane' Spa

Sources (1)

FDA UDI 83d9b3c5-76fd-4202-a6c6-e2a4efb132ab 36 fields · synced May 30, 2026