AccessGUDID - DEVICE: FlexCath™ Select (00643169688858)

GUDID

Device Identifier (DI) Information

Brand Name: FlexCath™ Select
Version or Model: 990065
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00643169688858
Issuing Agency: GS1
Commercial Distribution End Date: May 10, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 006261481 *Terms of Use

Device Description: SHEATH 990065 FLEXCATH SELECT 10 FR 65CM

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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:	Yes
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?
36079	Haemostasis valve	A noninvasive device designed as a conduit through which a small-diameter diagnostic/interventional device(s) can be introduced into or withdrawn from a patient's vasculature while preventing backflow of blood; it might in addition be intended for urinary applications. It is intended to be attached, typically via Luer-lock, to an invasively-placed catheter introducer (not included) and typically has a self-sealing lumen(s) [e.g., Touhy-Borst valve] and sideport for the introduction of solutions. It may include noninvasive guidewire accessories (e.g., guidewire introducer). It is not designed to be connected between tubing (i.e., not an in-line valve). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DYB	INTRODUCER, CATHETER
DRA	CATHETER, STEERABLE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K163268	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep dry
Special Storage Condition, Specify: Fragile, handle with care
Storage Environment Humidity: less than 85 Percent (%) Relative Humidity
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit
Handling Environment Temperature: between -31 and 136 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Usable length 65 cm
Device Size Text, specify: Dilator inner diameter 1 mm
Device Size Text, specify: Sheath inner diameter 10 Fr (3.3 mm)

Device Record Status

Public Device Record Key: dff59886-98f7-425e-841f-1825f98301ec
Public Version Date: July 31, 2023
Public Version Number: 5
DI Record Publish Date: May 19, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)633-8766
Email: Corporate.UDI@medtronic.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES