FDA.reportPublic FDA data

Epimed

Primary DI
00818788021540
Brand
Epimed
Company
EPIMED INTERNATIONAL, INC
Model
1911-221
Catalog number
1911-221
Device description
Nexus™ Epidural Catheter Connector 21g
Published
2017-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAZAnesthesia conduction kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAZAnesthesia Conduction KitAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051171000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051171000STINGRAY EPIDURAL CATHETER CONNECTOREpimed International, Inc.2005-08-26CAZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818788021547PackageGS110In Commercial Distribution
00818788021540PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081878802154710818788021547
00818788021540008187880215408187880215400818788021540

GMDN Terms#

Term, Definition table
TermDefinition
Luer/Luer linear connector, single-useA small, non-powered, noninvasive tubular, two-way/linear connector with a Luer connection (either lock or slip) at both ends intended to connect two luminal devices (e.g., catheter, tubing, container) with each other. It may have a straight or elbow shape; it does not incorporate a filter, valve, clamp, tubing nor puncturing component. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature50 Degrees Fahrenheit90 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(800)866-3342customerservice@epimed.com

Regulatory Flags#

DUNS number
799751953
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818788022998Epimed International, Inc.104-13142026-03-17
10818788022995Epimed International, Inc.104-13142026-03-17
00818788022295Epimed International, Inc.401-PBSYS2025-12-05
00818788021892Epimed International, Inc.325-4LRFG325-4LRFG2025-11-21
00818788022943Epimed International, Inc258-2205258-22052025-11-21
00818788022950Epimed International, Inc259-2010259-20102025-11-21
00818788022967Epimed International, Inc284-2010284-20102025-11-21
00818788022981Epimed291-C04291-C042017-10-24
00818788023650Epimed282-16102024-06-04
00818788023667Epimed282-16152024-06-04
00818788023681Epimed107-1618107-16182023-11-21
00818788021472Epimed189-2340189-23402017-10-24
00818788021564Epimed270-2015270-20152017-10-24
00818788021922Epimed265-2010265-20102017-10-24
00818788021939Epimed265-2015265-20152017-10-24
00818788021977Epimed268-2010268-20102017-10-24
00818788022066Epimed268-2015268-20152017-10-24
00818788022097Epimed270-2010270-20102017-10-24
00818788023599Epimed125-1820T125-1820T2021-06-17
00818788021281Epimed170-2124170-21242017-10-24

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04048223088005SonoLong Echo NanoLine® NRFitPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223088050PlexoLong NanoLine® NRFit acc. MeierPajunk GmbH MedizintechnologieCAZ2026-06-10
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04048223088692SonoLong Echo NanoLine® NRFitPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223088708PlexoLong NanoLine® NRFit acc. MeierPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223088722PlexoLong NanoLine® NRFit acc. MeierPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223089873LOR NRFit 10ml, SlipPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223090466EpiLong CathPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223125267SonoLong SoftSecurePajunk GmbH MedizintechnologieCAZ2026-06-10
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10193489031782MedlineMEDLINE INDUSTRIES, INC.CAZ2022-03-04
10193489031799MedlineMEDLINE INDUSTRIES, INC.CAZ2022-03-04
04048223116869PLEXOLONGPajunk GmbH MedizintechnologieCAZ2021-07-07
04048223116883PLEXOLONGPajunk GmbH MedizintechnologieCAZ2021-07-07
04048223117088STIMULONG SONOPajunk GmbH MedizintechnologieCAZ2021-07-07
04048223117187PLEXOLONG NANOPajunk GmbH MedizintechnologieCAZ2021-07-07
04048223117309SONOLONG ECHOPajunk GmbH MedizintechnologieCAZ2021-07-07
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10381780429531Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-22