FDA.reportPublic FDA data

sam(R) Advanced Gel Capture Patch

Primary DI
00857599005165
Brand
sam(R) Advanced Gel Capture Patch
Company
ZETROZ SYSTEMS, LLC
Model
UB-14
Catalog number
UB-14-15W
Device description
coupling patch for use with sam wearable ultrasound device
Published
2024-10-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
PFWStationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PFWStationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep HeatPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191568000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191568000sam 2.0 Long Duration Ultrasound SystemZetrOZ Systems, LLC2020-03-06PFW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857599005165PackageGS14In Commercial Distribution
00857599005257PrimaryGS10
00857599005103Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857599005165008575990051658575990051650857599005165
00857599005257008575990052578575990052570857599005257
00857599005103008575990051038575990051030857599005103

GMDN Terms#

Term, Definition table
TermDefinition
Skin topical coupling gelA medium designed to be applied to a patient's unbroken skin surface (excludes the eye surface) to provide a coupling between an analytical or therapeutic device (e.g., ultrasound transducer, optical glucose monitoring system, transcutaneous electrical stimulator) and the patient, allowing for the emission and reception of energy/signals (e.g., electrical current, light) that pass through the skin during an examination or treatment. It is in the form of a fluid-like gel that may also assist in moving the parent device smoothly over the skin. It may be used by a healthcare professional in a clinical setting and layperson in the home. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080128497
Device count
15
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857599005271sam 2.0 OA multi-hour continuous ultrasound device for home useSAM 2.0 OA24OA242026-04-07
00857599005257sam(R) Advanced Gel Capture PatchUB-14UB-14-15W2024-10-10
00857599005172sam(R) Advanced Gel Capture PatchUB-14UB14-15T2024-10-10
00857599005097sam coupling patchUB-122016-10-10
00857599005202sam X1SA551SA5512022-09-29
00857599005196sam 2.0 Long Duration Ultrasound Device for Home UseSA2712021-11-30
00857599005073samsam-122016-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00857599005271sam 2.0 OA multi-hour continuous ultrasound device for home useZETROZ SYSTEMS, LLCPFW2026-04-07
00850033615227Echo Ultrasound Device (PRC) THERMOTEK, INC.PFW2026-02-23
00850033615258Echo Ultrasound Device (PRC)THERMOTEK, INC.PFW2026-02-23
00850033615289Echo Ultrasound Device (USA)THERMOTEK, INC.PFW2026-02-23
00850033615340Echo Ultrasound Device (USA)THERMOTEK, INC.PFW2026-02-23
00850033615371Echo BOX, DRESSING & GEL POD PACK, USND, PRCTHERMOTEK, INC.PFW2026-02-23
00850033615388Echo CTN, DRESSINGS, USND, PRC, QTY 4 BOXESTHERMOTEK, INC.PFW2026-02-23
00850033615425Echo Ultra Sound Gel Pods, CartonTHERMOTEK, INC.PFW2026-02-23
00850033615487Echo Ultra Sound Gel Pod, SingleTHERMOTEK, INC.PFW2026-02-23
00850033615500Echo APPLICATOR, SINGLE, USNDTHERMOTEK, INC.PFW2026-02-23
00850033615517Echo POWER SUPPLY, CORD, SINGLE, USNDTHERMOTEK, INC.PFW2026-02-23
00850033615531Echo BELT CLIP, DEVICE PRTCTR, SNGL,USNDTHERMOTEK, INC.PFW2026-02-23
00850033615555Echo ARM STRAP, DEVICE PRTCTR, SNG, USNDTHERMOTEK, INC.PFW2026-02-23
00850033615562Echo GEL, TUBE, SINGLE, USNDTHERMOTEK, INC.PFW2026-02-23
00850033615586echoRx, MANUAL, USER, SINGLE, USNDTHERMOTEK, INC.PFW2026-02-23
00850033615593echoRx, GUIDE,QUICK START,SNGL,USNDTHERMOTEK, INC.PFW2026-02-23
00850033615623Echo CTN, DRESSINGS, USND, USA, QTY 4 BOXESTHERMOTEK, INC.PFW2026-02-23
00850033615630Echo BOX, DRESSING & GEL POD PACK, USND, USATHERMOTEK, INC.PFW2026-02-23
00810113682778ManaMed Transducer Holder PatchManamed, Inc.PFW2025-09-11
00810113682754ManaMed Transducer Fixation StrapManamed, Inc.PFW2025-09-11
00810113682761ManaMed Transducer Fixation StrapManamed, Inc.PFW2025-09-11
00857599005257sam(R) Advanced Gel Capture PatchZETROZ SYSTEMS, LLCPFW2024-10-10
00857599005172sam(R) Advanced Gel Capture PatchZETROZ SYSTEMS, LLCPFW2024-10-10
07290103422011PainShield PatchNANOVIBRONIX INC.PFW2023-07-24
07290103421144PainShield 3.0 ActuatorNANOVIBRONIX INC.PFW2023-07-16
07290103421328PainShield Plus Actuator NANOVIBRONIX INC.PFW2023-07-16
07290103422028PainShield 3.0 Driver NANOVIBRONIX INC.PFW2023-07-16
07290103422035PainShield Plus 3.0 Driver NANOVIBRONIX INC.PFW2023-07-16
00857599005202sam X1ZETROZ SYSTEMS, LLCPFW2022-09-29
00810113682396ManaSport+Manamed, Inc.PFW2022-06-20