FDA.reportPublic FDA data

EXMOOR

Primary DI
05060180252113
Brand
EXMOOR
Company
EXMOOR PLASTICS LIMITED
Model
EPL/1a
Catalog number
EPL1A
Device description
Epidrum
Published
2018-09-21
Public version status
Update
Distribution status
Not 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
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093863000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093863000EPIDRUMExmoor Plastics , Ltd.2010-05-10FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060180252113PackageGS1100Not in Commercial Distribution
05060180258788PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060180252113050601802521135060180252113
05060180258788050601802587885060180258788

GMDN Terms#

Term, Definition table
TermDefinition
Manual epidural space locatorA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a clean, dry environment, at room temperature. Avoid extremes of temperature and humidity.
Special Storage Condition, Specify00Store out of direct sunlight.
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
false
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
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05391530754620Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754699Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754941NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754965NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530753968Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754088Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754194Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754224Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754231Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530753456Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753463Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753487Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753517Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753524Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753531Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753548Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753555Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753562Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753579Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753593Polycarbonate syringe -DMC MEDICAL LIMITEDFMF2026-06-01
05391530753609Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753616Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753623Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753647Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753654Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753661Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753678Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01