FDA.reportPublic FDA data

Epimed

Primary DI
00818788021908
Brand
Epimed
Company
EPIMED INTERNATIONAL, INC
Model
412-CCET
Catalog number
412-CCET
Device description
PainBlocker™ Console Exhaust Tubing
Published
2017-10-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXHDEVICE, SURGICAL, CRYOGENIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXHDevice, Surgical, CryogenicNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00818788021908PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818788021908008187880219088187880219080818788021908

GMDN Terms#

Term, Definition table
TermDefinition
Liquid nitrous oxide coaxial tubingA sterile, double lumen (coaxial) tube in a straight or spiral design used to conduct liquid nitrous oxide (N2O) from an N2O cylinder to a medical device to act as a refrigerant typically for cryotherapy, e.g., cardiac cryoablation. It is typically constructed of polymeric material and may be available in various lengths. The coaxial design (inner and outer tubing) facilitates the removal of the exhaust N2O gases. 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

Contacts#

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

Regulatory Flags#

DUNS number
799751953
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00818788022295Epimed International, Inc.EPIMED INTERNATIONAL, INCGXH2025-12-05
10840143917004AtriCure cryoICE cryoXTATRICURE, INC.GXH2025-10-01
10840143912863AtriCure cryoICE cryoXTATRICURE, INC.GXH2025-04-25
30840143912867AtriCure cryoICE cryoXTATRICURE, INC.GXH2025-04-25
10840143911729AtriCure cryoICE cryoSPHERE+ Cryoablation SystemATRICURE, INC.GXH2024-02-15
10840143911736AtriCure cryoICE cryoSPHERE+ Cryoablation SystemATRICURE, INC.GXH2024-02-15
10840143911743AtriCure cryoICE cryoSPHERE MAX Cryoablation SystemATRICURE, INC.GXH2024-02-15
10840143911750AtriCure cryoICE cryoSPHERE MAX Cryoablation SystemATRICURE, INC.GXH2024-02-15
00816287020149iovera Smart TipPacira Pharmaceuticals, Inc.GXH2023-06-15
00816287020187iovera Smart TipPacira Pharmaceuticals, Inc.GXH2023-06-15
00816287020217iovera Smart TipPacira Pharmaceuticals, Inc.GXH2023-06-15
00816287020231iovera Smart TipPacira Pharmaceuticals, Inc.GXH2023-06-15
00816287020132iovera Smart TipPACIRA CRYOTECH, INC.GXH2023-06-15
00816287020170iovera Smart TipPACIRA CRYOTECH, INC.GXH2023-06-15
00816287020200iovera Smart TipPACIRA CRYOTECH, INC.GXH2023-06-15
00816287020224iovera Smart TipPACIRA CRYOTECH, INC.GXH2023-06-15
00816287020248ioveraPacira Pharmaceuticals, Inc.GXH2023-06-13
10840143902307cryoICE Cryoablation SystemATRICURE, INC.GXH2021-01-08
10840143902321AtriCure cryoICE Cryoablation System (CRYO2)ATRICURE, INC.GXH2021-01-08
10840143902543AtriCure cryoICE cryoSPHERE Cryoablation SystemATRICURE, INC.GXH2021-01-08
10840143902550AtriCure cryoICE cryoSPHERE Cryoablation SystemATRICURE, INC.GXH2021-01-08
30840143902608cryoICE Cryoablation SystemATRICURE, INC.GXH2021-01-08
30840143902646AtriCure cryoICE Cryoablation System (CRYO2)ATRICURE, INC.GXH2021-01-08
30840143902912AtriCure cryoICE cryoSPHERE Cryoablation SystemATRICURE, INC.GXH2021-01-08
30840143902929AtriCure cryoICE cryoSPHERE Cryoablation SystemATRICURE, INC.GXH2021-01-08
00818354017885AtriCure cryoICE Cryoablation System (CRYO2)ATRICURE, INC.GXH2020-03-18
00816287020071ioveraPacira Pharmaceuticals, Inc.GXH2020-02-12
00818354016321AtriCure cryoICE cryoSPHERE Cryoablation SystemATRICURE, INC.GXH2018-11-15
00818354016338AtriCure cryoICE cryoSPHERE Cryoablation SystemATRICURE, INC.GXH2018-11-15
00818354016123cryoICE Cryoablation SystemATRICURE, INC.GXH2018-04-01