FDA.reportPublic FDA data

EXMOOR

Primary DI
05060180251963
Brand
EXMOOR
Company
EXMOOR PLASTICS LIMITED
Model
L1
Catalog number
L1
Device description
Cream Ointment Ear Syringe
Published
2018-09-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRDApplicator, Ent Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRDApplicator, Ent DrugEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060180251963PackageGS150In Commercial Distribution
05060180256319PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060180251963050601802519635060180251963
05060180256319050601802563195060180256319

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe, single-useA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. 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 clean, dry environment at room temperature, avoid extremes of temperature and humidity
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
298725490
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
05060180256159EXMOORE.301E3012018-09-10
05060180251048EXMOORN18N182018-09-14
05060180251062EXMOORN23N232018-09-17
05060180251642EXMOORMK/82/A/E107MK82AE1072018-10-09
05060180251659EXMOORMK/82/A/E108MK82AE1082018-10-09
05060180252083EXMOORE.302E.3022018-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00714646000729OtoClear SprayWash System, Single UseBionix, LLCLRD2024-07-11
0071464600074327245Bionix, LLCLRD2024-07-11
0071464600075027275Bionix, LLCLRD2024-07-11
00859911004795Tabletop Waterpik Adapter WandsBionix, LLCLRD2024-07-11
00859911004801Portable WaterPik Adapter WandsBionix, LLCLRD2024-07-11
00714646000736OtoClear SprayWash System, Single Use SampleBionix, LLCLRD2024-07-11
10859911004792Tabletop Waterpik Adapter WandsBionix, LLCLRD2024-07-11
00714646000675Ear Wax Removal KitBionix, LLCLRD2024-07-11
00714646001177SprayWash Adapter WandBionix, LLCLRD2023-08-09
00714646000477OtoClear Ear Irrigation System WandsBionix, LLCLRD2023-07-21
10714646000474OtoClear Ear Irrigation System WandsBionix, LLCLRD2023-07-21
06936189900746WUSHGUANGDONG OKAY TECHNOLOGY CO.,LTD.LRD2023-03-06
06936189900753WUSHGUANGDONG OKAY TECHNOLOGY CO.,LTD.LRD2023-03-06
00714646000965OtoClear® Ear Irrigation System (220V)Bionix, LLCLRD2022-10-27
00714646000972OtoClear® Ear Irrigation System (220V)Bionix, LLCLRD2022-10-27
0071464600098927247Bionix, LLCLRD2022-10-27
00859911004290OtoClear® Spray Wash KitBionix, LLCLRD2022-01-07
00859911004887OtoClear® Aquabot® KitBionix, LLCLRD2022-01-07
00859911004894OtoClear® Aquabot® KitBionix, LLCLRD2022-01-07
05060180256319EXMOOREXMOOR PLASTICS LIMITEDLRD2018-09-10
00859911004146Bionix Development CorporationBionix, LLCLRD2017-01-28
00859911004153Bionix Development CorporationBionix, LLCLRD2017-01-28