AccessGUDID - DEVICE: Crono (08050616612007)

GUDID

Device Identifier (DI) Information

Brand Name: Crono
Version or Model: S-PID 50
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CANE' SPA

Primary DI Number: 08050616612007
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 438017964 *Terms of Use

Device Description: The CRONO S-PID 50 is an ambulatory syringe infusion pump intended exclusively for the controlled subcutaneous administration of immunoglobulin.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61514	Ambulatory non-insulin infusion pump, electronic	A battery-powered ambulatory device intended to provide continuous or intermittent administration of medication, commonly for antibiotic therapy, chemotherapy, or patient-controlled analgesia (PCA); it is not dedicated to insulin infusion. It consists of a small unit with a pumping mechanism and an infusion-rate controller. It is used with a dedicated single-use medication cartridge and/or an injection/infusion set for delivery via an intravenous, subcutaneous, arterial, epidural or intracavital route. It is typically worn in a case attached to the belt, carried in a pocket or bag, for ambulation within and outside healthcare settings; it may be designed for optional pole mounting.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRN	Pump, Infusion

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K091042	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fc7d14c9-999a-4a16-9522-e02ed89d5821
Public Version Date: August 07, 2024
Public Version Number: 6
DI Record Publish Date: October 06, 2016