AccessGUDID - DEVICE: Reusable Irrigation Tubing Set 2.2 m (04251783104164)

GUDID

Device Identifier (DI) Information

Brand Name: Reusable Irrigation Tubing Set 2.2 m
Version or Model: 04719400
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Assamed GmbH - Medizinbedarf

Primary DI Number: 04251783104164
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 319354346 *Terms of Use

Device Description: Reusable Irrigation Tubing Set 2.2 m

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:	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?
64108	Suction/irrigation tubing, reusable	A length of flexible noninvasive tube, typically made of synthetic polymer material(s), intended to interface between suction and/or irrigation devices (e.g., catheters, pumps, collection bottles) during a medical/surgical procedure (not dedicated to ophthalmic use); it might additionally be intended for use during reusable device reprocessing. The tubing may be provided in rolls from which required lengths are cut, or may be provided in predetermined lengths with connectors; it does not include additional associated items such as a clamp, spike, or bag (i.e., not a tubing set). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EFS	Unit, Oral Irrigation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 2.2 Meter

Device Record Status

Public Device Record Key: f2eb729c-f60c-4e67-8127-64cca0d8e5d1
Public Version Date: April 10, 2023
Public Version Number: 1
DI Record Publish Date: March 31, 2023