FDA.reportPublic FDA data

ACE

Primary DI
00614950008759
Brand
ACE
Company
ACE SURGICAL SUPPLY CO., INC.
Model
0030430
Catalog number
0030430
Device description
"ELECTRODE FOAM ROUND 2"" DIA 30/BAG L/F"
Published
2017-01-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRXElectrode, electrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRXElectrode, ElectrocardiographCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10614950008756PackageGS130In Commercial Distribution
00614950008759PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1061495000875610614950008756
00614950008759006149500087596149500087590614950008759

GMDN Terms#

Term, Definition table
TermDefinition
Electrode conductive skin pad, single-useA noninvasive conductive material designed to facilitate electrical conduction between an external electrode (e.g., paddle-type defibrillator electrode) and the skin surface. It is available in various forms such as a thickened gel or polymer medium reinforced by a non-woven material, an adhesive pad/patch, or an absorbent material (e.g., felt) intended to be soaked in a conduction fluid. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length11Inch
Width7Inch

Contacts#

Phone, Email table
PhoneEmail
+1(508)588-3100ritaknight@acesurgical.com

Regulatory Flags#

DUNS number
042763706
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00614950007547OUSIA bioXENOUSM2OUSM22015-10-24
00614950007554OUSIA bioXENOUSM3OUSM32015-10-24
00614950007561OUSIA bioXENOUSM4OUSM42015-10-24
00614950007578OUSIA bioXENOUSM5OUSM52015-10-24
00614950007585OUSIA bioXENOUSM6OUSM62015-10-24
00614950007721OUSIA bioXENOUSM1OUSM12015-10-24
00614950027910Collagen Matrix509400150940012023-06-16
00614950027927Collagen Matrix509400250940022023-06-16
00614950027934MinerOss® XBH0034BH00342022-10-27
00614950027941MinerOss® XBH0035BH00352022-10-27
00614950027958MinerOss® XBH0036BH00362022-10-27
00614950027965MinerOss® XBH0037BH00372022-10-27
00614950027972MinerOss® XBH0038BH00382022-10-27
00614950027989MinerOss® XBH0039BH00392022-10-27
00614950027996MinerOss® XBH0044BH00442022-10-27
00614950028009MinerOss® XBH0045BH00452022-10-27
00614950028016MinerOss® XBH0046BH00462022-10-27
00614950028023MinerOss® XBH0047BH00472022-10-27
00614950028030MinerOss® XBH0052BH00522022-10-27
00614950028047MinerOss® XBH0053BH00532022-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850018561006ECG Patient CableINTERNATIONAL BIOMEDICAL, LTD.DRX2026-10-13
19005531000978SkintactLeonhard Lang GmbHDRX2026-10-12
20885380213202KendallCardinal Health 200, LLCDRX2026-08-18
10850078465006NIKOTRACENIKOMED USADRX2026-08-17
10850078465013NIKOTRACENIKOMED USADRX2026-08-17
10850078465020NIKOTRACENIKOMED USADRX2026-08-17
05060038511034Ambu® WhiteSensor 40554Ambu A/SDRX2026-08-07
00851491007555AccuSensorLynn Medical Instrument Co.DRX2026-07-28
00851491007562AccuSensorLynn Medical Instrument Co.DRX2026-07-24
G828HARNESS0PhysiotraceNimbleHeart, Inc.DRX2026-05-28
G828PACKAGE0PhysiotraceNimbleHeart, Inc.DRX2026-05-28
00860002238500Piccolo MedicalPiccolo Medical, Inc.DRX2026-05-06
08809083949129TELECTRODEBIOPROTECH INC.DRX2026-04-30
08809083949136TELECTRODEBIOPROTECH INC.DRX2026-04-30
00860002238586Piccolo MedicalPiccolo Medical, Inc.DRX2025-11-07
10841522130755Eclipse MiniSPACELABS HEALTHCARE (WASHINGTON), INCDRX2024-06-07
20192253016632KendallCardinal Health 200, LLCDRX2024-02-28
20192253016663KendallCardinal Health 200, LLCDRX2024-02-28
20192253016670KendallCardinal Health 200, LLCDRX2024-02-28
20192253016830KendallCardinal Health 200, LLCDRX2024-02-28
20192253017424KendallCardinal Health 200, LLCDRX2024-02-28
20192253017813KendallCardinal Health 200, LLCDRX2024-02-28
20192253018506Uni-PatchCardinal Health 200, LLCDRX2024-02-28
20192253017080KendallCardinal Health 200, LLCDRX2023-03-16
10841522130298Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCDRX2023-02-23
20192253016748KendallCardinal Health 200, LLCDRX2021-05-19
08033003267424NAFIAB SPADRX2021-03-31
20192253016755KendallCardinal Health 200, LLCDRX2021-02-23
20192253017349KendallCardinal Health 200, LLCDRX2021-02-23
20192253017196KendallCardinal Health 200, LLCDRX2020-11-17