FDA.reportPublic FDA data

Curaplex

Primary DI
00815277023917
Brand
Curaplex
Company
BOUND TREE MEDICAL, LLC
Model
16383
Device description
Curaplex Select Multi-Function Defib Pads, Physio-Control Pediatric 10pr/cs
Published
2016-12-14
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
LDDDc-defibrillator, low-energy, (including paddles)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDDDc-Defibrillator, Low-Energy, (Including Paddles)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081442000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081442000HEART SYNC PEDIATRIC, MODEL PED-100Heart Sync, LLC2008-09-24LDD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815277023924PackageGS110In Commercial Distribution
00815277023917PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815277023924008152770239248152770239240815277023924
00815277023917008152770239178152770239170815277023917

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.

Regulatory Flags#

DUNS number
070556204
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817617027630Curaplex1124-324001124-324002023-03-30
00810094574802Curaplex301-PrO2LT301-PrO2LT2023-04-10
00810094574819Curaplex301-PrO2LT-MSA301-PrO2LT-MSA2023-04-10
00810094574826Curaplex301-PrO2LTEZ-MM301-PrO2LTEZ-MM2023-04-10
00810094574833Curaplex301-PrO2LTEZ-MSA301-PrO2LTEZ-MSA2023-04-10
00810094574840Curaplex301-PrO2LTEZ301-PrO2LTEZ2023-04-10
00810094574857Curaplex301-PrO2LT-FM301-PrO2LT-FM2023-04-10
00810094574864Curaplex301-PrO2LT-0301-PrO2LT-02023-04-10
00810094574871Curaplex301-PrO2LTEZ-MF301-PrO2LTEZ-MF2023-04-10
00810094573072Curaplex301-44F10-120301-44F10-1202022-04-30
00810094573089Curaplex301-44F50-100301-44F50-1002022-04-30
00812277032024Curaplex301-44F50-100301-44F50-1002018-12-15
00812277032055Curaplex301-44F10-120301-44F10-1202018-12-15
00818834028356Curaplex301-12218301-122182022-04-30
00199972000801Curaplex670293-KIT670293-KIT2026-09-30
00199972000825Curaplex670294-KIT2026-09-30
00199972000849Curaplex670295-KIT670295-KIT2026-09-30
00199972000863Curaplex670296-KIT670296-KIT2026-09-30
00199972000887Curaplex670297-KIT670297-KIT2026-09-30
00199972000900Curaplex670298-KIT670298-KIT2026-09-30

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Primary DI, Brand, Company table
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00817392025289UnipowerUNIPOWER CORPORATIONLDD2021-04-30
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