FDA.reportPublic FDA data

Autopen

Primary DI
00384703810013
Brand
Autopen
Company
OWEN MUMFORD LIMITED
Model
AN3810
Catalog number
AN3810
Device description
1-unit non-sterile pen injector
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
K983974000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K983974000OWEN MUMFORD 3ML AUTOPENOwen Mumford USA, Inc.1998-12-21FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00384703810037PackageGS1100In Commercial Distribution
00384703810013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00384703810037003847038100373847038100370384703810037
00384703810013003847038100133847038100130384703810013

GMDN Terms#

Term, Definition table
TermDefinition
Cartridge-accepting autoinjector, mechanicalA portable, hand-held, mechanical device, typically in the form of a large pen, designed to accept a pharmaceutical-containing cartridge (not included) and intended to be used by a patient to subcutaneously inject a dose of the pharmaceutical agent via a replaceable needle. The cartridge is inserted into the device and typically a dial on the device is operated for dosing (e.g., via a spring-loaded mechanism); the cartridge is replaced once the pharmaceutical is exhausted. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length165Millimeter
Width15Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+441993812021info@owenmumford.co.uk

Regulatory Flags#

DUNS number
217266915
Device count
1
Kit
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
00384703800014Autopen AN3800AN38002016-09-19
00384700752019Unistik 2 Safety Lancets - Super 18GAT 07522020-04-16
00384701402012Unistik TouchAT 14022023-03-30
00384701402036Unistik TouchAT 14022023-03-30
00384700702014UnistikAT 07022020-04-16
00384700704018UnistikAT 07042020-04-16
00384700712013Unistik AT 07122020-04-16
00384700714017Unistik AT 07142020-04-16
00384700747015Unistik AT 07472020-04-16
00384701422010Unistik TouchAT 14222021-03-26
00384701442018Unistik Touch AT 14422021-03-26
00384701015014Unistik AT 10152023-02-07
00384701027017Unistik 3AT 10272023-02-07
00384701614019Unistik ProAT 16142023-02-07
00384701634017Unistik ProAT 16342023-02-07
00384701644016Unistik ProAT 16442023-02-07
00384701015038Unistik AT 10152023-02-07
00384701027024Unistik 3AT 10272023-02-07
00384701614033Unistik ProAT 16142023-02-07
00384701634031Unistik ProAT 16342023-02-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450492888Merit Medical®Merit Medical Systems, Inc.FMF2026-07-22
10383017593015Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593213Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593411Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593510Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593718Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844612Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844711Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844919Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
18257200121076O-GENESISOrthofix US LLCFMF2026-07-17
18257200121083O-GENESISOrthofix US LLCFMF2026-07-17
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05391530754699Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754941NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754965NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
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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