AccessGUDID - DEVICE: EXMOOR (05060180252083)

GUDID

Device Identifier (DI) Information

Brand Name: EXMOOR
Version or Model: E.302
Commercial Distribution Status: In Commercial Distribution
Catalog Number: E.302
Company Name: EXMOOR PLASTICS LIMITED

Primary DI Number: 05060180252083
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 298725490 *Terms of Use

Device Description: Garth Nasal Mop

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?
46743	Cotton bud	A device typically designed as an absorbent, non-sterile pledget of cotton on a wooden, paper, or plastic stick, with a single- or a double-ended tip, intended to be used within the healthcare sector or the home, or within the manufacturing/service industries. Commonly known as cotton buds, it has uses that range from cleaning wax from the outer ear canal, to applying substances/cosmetics to the body, to cleaning electronics. It is used within the healthcare sector or the home and is normally available [non-prescription] over-the-counter (OTC). This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KXF	Applicator, Absorbent Tipped, Non-Sterile

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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 35 Degrees Celsius
Special Storage Condition, Specify: Store in a dry environment. Avoid extremes of temperature and humidity.
Special Storage Condition, Specify: Keep out of direct sunlight.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 18e19748-c1d2-42f6-8dce-b19305551397
Public Version Date: October 22, 2018
Public Version Number: 1
DI Record Publish Date: September 21, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
05060180251932	100	05060180252083		In Commercial Distribution

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: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +441823351040
Email: sales@exmoorltd.com

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