AccessGUDID - DEVICE: EXMOOR (05060180258269)

GUDID

Device Identifier (DI) Information

Brand Name: EXMOOR
Version or Model: SC4JH
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SC4JH
Company Name: EXMOOR PLASTICS LIMITED

Primary DI Number: 05060180258269
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 298725490 *Terms of Use

Device Description: Suction Clearance Kit

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:	Yes
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?
13846	Secretion suction kit	A collection of items intended for suctioning secretions from a patient; typically included are sterile gloves, a suction catheter, and a container for collecting the secretions. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LRC	INSTRUMENT, ENT MANUAL SURGICAL

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
Special Storage Condition, Specify: store in clean, dry environment at room temperature, avoid extremes of temperature 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: bf40633c-0347-4f39-9447-dc2d79122c4e
Public Version Date: May 20, 2022
Public Version Number: 1
DI Record Publish Date: May 12, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
05060180251055	10	05060180258269		In Commercial Distribution	Box

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: Yes
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: +4401204529494
Email: Regulatory.Affairs@vernagroup.com

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

FDA TOOLS & RESOURCES