AccessGUDID - DEVICE: Anorectal Manometry Catheter (00627825001076)

GUDID

Device Identifier (DI) Information

Brand Name: Anorectal Manometry Catheter
Version or Model: CAT003
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Laborie Medical Technologies Canada ULC

Primary DI Number: 00627825001076
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 203383526 *Terms of Use

Device Description: Kateter för Anorektal Tryckmätning

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
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?
62244	Urodynamic manometric catheter, non-electronic	A sterile, non-electrical, long flexible tube intended to be inserted into the bladder via the urethra, or a stoma, for measuring urethral/bladder pressure, urinary output, other urethral and voiding pressures, and/or cystometry. The measuring method employed is typically the infusion of water (water-perfused catheter) or insufflation of air/gas (air-charged catheter) into the catheter, whereby pressure signals are conducted to proximally-connected external pressure transducers in urodynamic examination equipment. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FFX	SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K963064	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: a00e5c77-8532-44dd-a1b5-a1e85538aa9a
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 21, 2016