FDA.reportPublic FDA data

Epimed

Primary DI
00818788023568
Brand
Epimed
Company
EPIMED INTERNATIONAL, INC
Model
159-2124
Catalog number
159-2124
Device description
"Versa-Kath® with Small Bore Connector 21g x 24"""
Published
2021-02-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BSOCATHETER, CONDUCTION, ANESTHETIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSOCatheter, Conduction, AnestheticAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K023140000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023140000VERSA-KATH EPIDURAL CATHETER, MODEL 156-2124Epimed International, Inc.2003-08-15BSO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818788023565PackageGS110In Commercial Distribution
00818788023568PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081878802356510818788023565
00818788023568008187880235688187880235680818788023568

GMDN Terms#

Term, Definition table
TermDefinition
Epidural anaesthesia set, non-medicatedA collection of devices intended for the administration of an analgesic or anaesthetic agent (not included) to the epidural space for the management of pain. It includes a needle and/or a catheter with additional procedural devices (e.g., syringe, dressings, guidewire, introducer), and may be intended for single- or continuous-administration. It is not intended for intrathecal anaesthesia This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge2.4French
Device Size Text, specify0
Device Size Text, specify0
Length24Inch

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
Kit
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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10801902207507ARROWTELEFLEX INCORPORATEDBSO2022-05-13
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10801902207569ARROWTELEFLEX INCORPORATEDBSO2022-04-29
10801902207682ARROWTELEFLEX INCORPORATEDBSO2022-04-29
10801902207743ARROWTELEFLEX INCORPORATEDBSO2022-04-29
10801902207842ARROWTELEFLEX INCORPORATEDBSO2022-04-29
10801902207446ARROWTELEFLEX INCORPORATEDBSO2022-04-11
10801902207668ARROWTELEFLEX INCORPORATEDBSO2022-04-11
10801902207736ARROWTELEFLEX INCORPORATEDBSO2022-04-11