SED-CONNECT

Primary DI
M445693ASAMPLE1
Brand
SED-CONNECT
Company
MEDICAL CHEMICAL CORPORATION
Model
693A-Sample
Catalog number
693A-Sample
Device description
SED-CONNECT is a closed concentration system for the recovery of eggs, larvae, and protozoa from preserved fecal specimens. This kit contains 10 sets of single use components.
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LKSDevice, Parasite Concentration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LKSDevice, Parasite ConcentrationMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K941129000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K941129000CON-KITMedical Chemical Corp.1994-05-09LKS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M445693ASAMPLE1PrimaryHIBCC0
M445693ASAMPLE0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Faecal parasite specimen concentration kit IVDA collection of devices intended to be used for the concentration and recovery of eggs, larvae, and cysts of intestinal parasites (e.g., pinworms) from a faecal specimen, for microscopic analysis and/or other investigation. The kit typically includes reagents, centrifuge tubes, and filters. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008496861
Device count
10
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Model table
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M445693A50PACK1SED-CONNECT693A 50 PACK693A 50 PACK2016-09-20
M445693AESEDEA50PACK1SED-CONNECT693A-E SED+EA693A-E SED+EA2016-09-20
M445693AFUNNEL1SED-CONNECT693A-FUNNEL693A-FUNNEL2016-09-20
M445694A1MICRO-SED694A694A2016-09-20
M445694AEA1MICRO-SED694A-EA694A-EA2016-09-20
M445694ASAMPLE1MICRO-SED694A-Sample694A-Sample2016-09-20
M445694ATUBEFUNNEL1MICRO-SED694A-TUBE/FUNNEL 1000694A-TUBE/FUNNEL 10002016-09-20
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