FDA.reportPublic FDA data

BodyMed

Primary DI
00815991022050
Brand
BodyMed
Company
BOXOUT, LLC
Model
ZZAI275
Catalog number
ZZAI275
Device description
"BODYMED IONTOPHORESIS, ELECTRODE SMALL 2.75"" X 2.75"", 12/BOX"
Published
2018-12-27
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
EGJDevice, Iontophoresis, Other Uses

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGJDevice, Iontophoresis, Other UsesPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080580000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080580000COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE DAxelgaard Mfg. Co., Ltd.2008-06-18EGJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815991022050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815991022050008159910220508159910220500815991022050

GMDN Terms#

Term, Definition table
TermDefinition
Drug-delivery iontophoresis patchA non-sterile device designed as a patch that is fixed on the skin, typically with a pressure-sensitive adhesive, intended to be used as an alternative to injections for the transport of ionic-solution medication (e.g., soluble salts) through the movement of ions, resulting from an applied electric field, to locally administer the medication transcutaneously (transdermal). It typically consists of a positive and a negative electrode, a reservoir/drug chamber(s) that hold the medication, a battery, and a perimeter adhesive; the reservoir must be filled by the user with the drug prior to use. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
066689993
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
00815991024405BodyMedBDMNEBCOM2022-07-01
00815991024412BodyMedBDMNEBDOG2022-07-01
00815991025167BodyMedBDMNEBCOMREU2025-07-17
00815991024047BodyMedBDMNTRGVMEDBDMNTRGVMED2024-12-04
00815991024054BodyMedBDMNTRGVSMBDMNTRGVSM2024-12-04
00815991024061BodyMedBDMNTRGVXLGBDMNTRGVXLG2024-12-04
00815991024078BodyMedBDMNTRGVXSBDMNTRGVXS2024-12-04
00815991024030BodyMedBDMNTRGVLRGBDMNTRGVLRG2024-12-04
20815991024041BodyMedBDMNTRGVMEDBDMNTRGVMED2024-12-04
20815991024058BodyMedBDMNTRGVSMBDMNTRGVSM2024-12-04
20815991024065BodyMedBDMNTRGVXLGBDMNTRGVXLG2024-12-04
20815991024072BodyMedBDMNTRGVXSBDMNTRGVXS2024-12-04
00815991025181BodyMedBDMPULSEOXBDMPULSEOX2024-10-11
20815991025185BodyMedBDMPULSEOXBDMPULSEOX2024-10-11
00815802010122BodyMedZZHP1427ZZHP14272016-09-05
00815802010139BodyMedZZHP1414ZZHP14142016-09-05
00815802010146BodyMedZZHP147ZZHP1472016-09-05
00815802010153BodyMedZZHP832UZZHP832U2016-09-05
00815802018715BodyMedZZHP1427BLKZZHP1427BLK2016-08-01
00815991022623BodyMedZZHPS1623ZZHPS16232019-10-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10768627016497Push Patch Controlled Released 12.0NORTH COAST MEDICAL, INC.EGJ2025-12-01
00768627016995PushPatch Delicate (6)NORTH COAST MEDICAL, INC.EGJ2025-12-01
00768627016988PushPatch Delicate (6)NORTH COAST MEDICAL, INC.EGJ2025-12-01
20768627016494Push Patch Controlled Released 12.0NORTH COAST MEDICAL, INC.EGJ2025-12-01
10768627016299ActivaTek Ionto4 KitNORTH COAST MEDICAL, INC.EGJ2025-04-02
10768627016305ActivaTek Ionto4 KitNORTH COAST MEDICAL, INC.EGJ2025-04-02
10768627016312ActivaTek Ionto4 ButterflyNORTH COAST MEDICAL, INC.EGJ2025-04-02
10768627016282ActivaTek Ionto4 KitNORTH COAST MEDICAL, INC.EGJ2025-04-02
20768627016296ActivaTek Ionto4 KitNORTH COAST MEDICAL, INC.EGJ2025-04-02
20768627016302ActivaTek Ionto4 KitNORTH COAST MEDICAL, INC.EGJ2025-04-02
20768627016319ActivaTek Ionto4 ButterflyNORTH COAST MEDICAL, INC.EGJ2025-04-02
04250571300832PhotheraHIDREX GmbHEGJ2025-01-07
08054383090006MATTIOLIMATTIOLI ENGINEERING ITALIA SPAEGJ2024-09-26
00850030915047Dupel BLUEClearlake-Tech Inc.EGJ2023-08-02
00850030915078Dupel BLUEClearlake-Tech Inc.EGJ2023-08-02
00850030915108Dupel BLUEClearlake-Tech Inc.EGJ2023-08-02
00850030915252RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915269RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915276RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915283RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915290RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915306RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915313RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915320RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915337RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915344RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915351RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915368RichmarSouth Dakota Partners Inc.EGJ2023-08-02
00850030915016Dupel BLUEClearlake-Tech Inc.EGJ2023-08-02
00850030915054Dupel BLUESouth Dakota Partners Inc.EGJ2023-08-02