DEVICE: EXMOOR (05060180254643)

Device Identifier (DI) Information

EXMOOR
EPL1
In Commercial Distribution
EPL1A or EPL1B
EXMOOR PLASTICS LIMITED
05060180254643
GS1

1
298725490 *Terms of Use
Epidrum
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FMF Syringe, Piston
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K093863 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Store in a clean, dry environment, at room temperature. Avoid extremes of temperature and humidity.
Special Storage Condition, Specify: Store out of direct sunlight.
Storage Environment Temperature: between 10 and 35 Degrees Celsius
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

6e3ccb59-2997-44e9-9f33-c8ed24a543dc
November 26, 2019
1
November 18, 2019
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
05060180256456 10 05060180254643 In Commercial Distribution a box
05060180256432 100 05060180254643 In Commercial Distribution a box
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+441823351040
sales@exmoorltd.com
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