FDA.reportPublic FDA data

Full Power AED

Primary DI
00867855000308
Brand
Full Power AED
Company
FULL POWER AED, LLC
Model
Rapid Hair Removal Pads
Device description
Adhesive Medical Device to remove chest hair before defibrillation
Published
2017-04-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
K150349000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150349000Rapid Hair Removal PadsFull Power Aed2015-07-14LDD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00867855000308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00867855000308008678550003088678550003080867855000308

GMDN Terms#

Term, Definition table
TermDefinition
Hypoallergenic skin adhesive tapeA flexible band of fabric, plastic, paper, or other material, coated on one side with a pressure-sensitive adhesive, and designed with a lower potential for producing an allergic reaction (i.e., hypoallergenic), intended to non-invasively adhere to the skin surface to fix a dressing in place, or attach objects (e.g., catheter); it is not waterproof. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height7.95Inch
Width5.872Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9194756088jahnpower@fullpoweraed.com

Regulatory Flags#

DUNS number
075191245
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817392026248UnipowerUNIPOWER CORPORATIONLDD2026-06-02
00817392026255UnipowerUNIPOWER CORPORATIONLDD2026-06-02
00817392026217UnipowerUNIPOWER CORPORATIONLDD2026-05-13
00817392026224UnipowerUNIPOWER CORPORATIONLDD2026-05-13
00817392026231UnipowerUNIPOWER CORPORATIONLDD2026-05-13
00817392025647UnipowerUNIPOWER CORPORATIONLDD2024-02-13
00817392025654UnipowerUNIPOWER CORPORATIONLDD2024-02-13
00817392025593UnipowerUNIPOWER CORPORATIONLDD2024-01-10
00817392025609UnipowerUNIPOWER CORPORATIONLDD2024-01-10
00817392025616UnipowerUNIPOWER CORPORATIONLDD2024-01-10
10888277634930MedlineMEDLINE INDUSTRIES, INC.LDD2021-10-22
10888277634954MedlineMEDLINE INDUSTRIES, INC.LDD2021-10-22
10888277634947MedlineMEDLINE INDUSTRIES, INC.LDD2021-09-16
00817392025289UnipowerUNIPOWER CORPORATIONLDD2021-04-30
07613365002737Tempus LS-MANUALSchiller AGLDD2020-08-11
08054242441765NAFIAB SPALDD2020-04-12
08054242441772NAFIAB SPALDD2020-04-12
08054242441789NAFIAB SPALDD2020-04-12
08054242441796NAFIAB SPALDD2020-04-12
08054242441802NAFIAB SPALDD2020-04-12
08054242441819NAFIAB SPALDD2020-04-12
08054242441826NAFIAB SPALDD2020-04-12
08054242441833NAFIAB SPALDD2020-04-12
08054242441840NAFIAB SPALDD2020-04-12
08054242441857NAFIAB SPALDD2020-04-12
08054242441871NAFIAB SPALDD2020-04-12
08054242441895NAFIAB SPALDD2020-04-12
08054242444933NAFIAB SPALDD2020-04-12
08054242446425NAFIAB SPALDD2020-04-12
08054242446432NAFIAB SPALDD2020-04-12