APO-GO Syringe reservoir

FDA UDI

Class II (US FDA UDI)

by Cane' Spa

Identity

Trade Name: APO-GO Syringe reservoir FDA UDI
Generic Name: General-purpose syringe, single-use FDA UDI
Device Name: 20 ml reservoir for Crono GO ambulatory syringe infusion pumps FDA UDI
Model / Reference: APO-GO/20/WN FDA UDI
Description: 20 ml reservoir for Crono GO ambulatory syringe infusion pumps FDA UDI

Identifiers

Primary DI / UDI-DI: 08050616611635 FDA UDI
510(k) Number: K052219 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 — 20 Milliliter FDA UDI

Category: General-purpose syringe, single-use

APO-GO 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.

Merit Medical® — Merit Medical Systems, Inc. · Class II
SOFT-JECT® — Henke-Sass, Wolf GmbH · Class II
CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
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

K052219 also covers:

Crono — CANE' SPA

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

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

Manufacturer

Manufacturer: Cane' Spa

Sources (1)

FDA UDI 05ba5f43-bca7-42b8-96b4-47d1d8afbd05 35 fields · synced Jun 8, 2026