Skip to content

Percutaneous Tracheostomy Introducer Tray

by Cook Incorporated

Ref C-PTISYJ-100-HC-G-EU-FLEX7.5

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

4 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0827002CINC001-001KJ Basic UDI-DI 00827002577244UDI-DIDate29 Mar 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00827002577244 UDI-DI Date27 Jul 2020ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

4 recalls · 4 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1779-2026 FDA Class II initiated 5 Mar 2026
    • Ongoing Z-1780-2026 FDA Class II initiated 5 Mar 2026

    Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

  • 2 recalls, same reason

    • Ongoing Z-1427-2023 FDA Class I initiated 7 Apr 2023
    • Ongoing Z-1428-2023 FDA Class I initiated 7 Apr 2023

    There were reports from customers that the tracheostomy in the sets and trays is not making a secure connection with the 15mm cap and other 15mm circuit components and accessories. This resulted in an unsecure connection between the device connector and circuit components, cap, or accessories.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Percutaneous Tracheostomy Introducer Tray EUDAMED
Blue Rhino GUDID
Generic Name
Tracheostomy kit, single-use
Device Name
Percutaneous Tracheostomy Introducer Set/Tray
Model / Ref / Catalog
C-PTISYJ-100-HC-G-EU-FLEX7.5, G57724
Primary DI / UDI-DI
00827002577244
Basic UDI-DI
0827002CINC001-001KJ
510(k) Number
FDA Product Code
JOH
EMDN Code
R010601 Ciaglia tracheostomy kits
GMDN Term
Tracheostomy kit, single-use
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
868.5800
Medical Purpose
intended for percutaneous dilational tracheostomy for management of the airway in adults only. Tube placement, using the technique described herein, should be performed in a controlled setting (e.g., ICU or operating room) with the assistance of trained personnel.
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
C-PTISYJ-100-HC-G-EU-FLEX7.5
GUDID
G57724
Device ClassEUDAMED
Class IIb
GUDID
Class II
SterileEUDAMED
No
GUDID
Yes

Manufacturer details

EUDAMED SRN
US-PR-000019790

Other devices from Cook Incorporated

See all devices from Cook Incorporated →

Properties

  • Sterile NoEUDAMEDYesGUDID
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No