AccessGUDID - DEVICE: EXMOOR (05060180257835)

GUDID

Device Identifier (DI) Information

Brand Name: EXMOOR
Version or Model: S1011/300
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: S1011/300
Company Name: EXMOOR PLASTICS LIMITED

Primary DI Number: 05060180257835
Issuing Agency: GS1
Commercial Distribution End Date: October 31, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 298725490 *Terms of Use

Device Description: Laryngeal Suction Tube

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):	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?
35917	Surgical/emergency suction cannula, non-illuminating, single-use	An atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JZF	Tube, Ear Suction

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 10 and 35 Degrees Celsius
Special Storage Condition, Specify: Keep out of direct sunlight.
Special Storage Condition, Specify: store in clean, dry environment at room temperature, avoid extremes of temerature and humidity.
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2dc7af6d-f178-4d48-b3ad-f2a80f9c1490
Public Version Date: April 20, 2020
Public Version Number: 4
DI Record Publish Date: September 14, 2018