EXMOOR

Basic Information

• Brand Name: EXMOOR
• Primary DI: 05060180258788
• Version / Model: EPL/1a
• Catalog Number: EPL1A
• Company Name: EXMOOR PLASTICS LIMITED
• Labeler DUNS: 298725490
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-21
• Public Version: 3
• Public Version Date: 2019-11-19
• Public Version Status: Update
• Public Device Record Key: a8b37ecb-d600-44fd-a9c3-b4533ca9caed
• Distribution End Date: 2019-11-01

Device Description

Epidrum

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMF	Syringe, Piston	General Hospital	880.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58220	Manual epidural space locator	A sterile device intended to be used in conjunction with an epidural needle to aid a user in locating the epidural needle tip within the epidural space. It is typically a small chamber made of synthetic polymers with Luer inlet and exit ports on opposing sides and an expandable membrane (diaphragm) as one of the sides between the ports. The device is inserted between the syringe and epidural needle and its diaphragm is inflated with air; the needle is inserted into the patient until the diaphragm collapses signalling entry into the epidural space. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05060180252113	GS1		100	Not in Commercial Distribution	2019-11-01
Primary	05060180258788	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K093863	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store out of direct sunlight.
• Type: Storage Environment Temperature
• Temperature Range: 10 – 35 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 20 – 80 Percent (%) Relative Humidity
• Type: Special Storage Condition, Specify
• Special Conditions: Store in a clean, dry environment, at room temperature. Avoid extremes of temperature and humidity.