FDA.reportPublic FDA data

EXMOOR

Primary DI
05060180256159
Brand
EXMOOR
Company
EXMOOR PLASTICS LIMITED
Model
E.301
Catalog number
E301
Device description
Mal Ear Mop
Published
2018-09-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KXFApplicator, Absorbent Tipped, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXFApplicator, Absorbent Tipped, Non-SterileGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060180251925PackageGS1100Not in Commercial Distribution
05060180256159PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060180251925050601802519255060180251925
05060180256159050601802561595060180256159

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose absorbent tip applicator/swab, single-useA hand-held manual device, also known as a cotton bud or swab, in the form of a stick with a single- or double-ended absorbent tip (e.g., cotton pledget), intended for cleaning or applying a substance (e.g., medication) to a superficial wound or body orifice, and/or to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is intended for use in a healthcare setting and/or in the home. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep out of direct sunlight.
Special Storage Condition, Specify00Store in a dry environment. Avoid extremes of temperature and humidity.
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius35 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+441823351040sales@exmoorltd.com

Regulatory Flags#

DUNS number
298725490
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060180256043EXMOORE.111E111 or E111X52018-09-10
05060180256180EXMOORE402E4022018-09-11
05060180256272EXMOORE.59E592018-09-20
05060180256319EXMOORL1L12018-09-10
05060180257798EXMOORS101S101-EX2018-09-11
05060180257866EXMOORS102S102-EX2018-09-11
05060180257873EXMOORS103S103-EX2018-09-11
05060180257880EXMOORS104S104-EX2018-09-11
05060180257934EXMOORS109S109-EX2018-09-11
05060180257972EXMOORS110S110-EX2018-09-11
05060180257989EXMOORS111S111-EX2018-09-11
05060180258139EXMOORS125S125-EX2018-09-11
05060180256258EXMOORE.58E582018-09-20
05060180256265EXMOORE.58aE58A2018-09-20
05060180251048EXMOORN18N182018-09-14
05060180251062EXMOORN23N232018-09-17
05060180251642EXMOORMK/82/A/E107MK82AE1072018-10-09
05060180251659EXMOORMK/82/A/E108MK82AE1082018-10-09
05060180252083EXMOORE.302E.3022018-09-21
05060180252106EXMOORSRS.6a(29)SRS6A(29)2018-09-21

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Primary DI, Brand, Company table
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