FDA.reportPublic FDA data

TD2 Patient Kit

Primary DI
00812537037127
Brand
TD2 Patient Kit
Company
NALU MEDICAL, INC.
Model
74011
Device description
A non-sterile kit containing two external wearable (2) therapy discs, one (1) Base Station Charger, wall adapter, USB Cable and a carrying case.
Published
2026-02-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GZBStimulator, Spinal-Cord, Implanted (Pain Relief)
GZFStimulator, Peripheral Nerve, Implanted (Pain Relief)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZBStimulator, Spinal-Cord, Implanted (Pain Relief)Neurology2
GZFStimulator, Peripheral Nerve, Implanted (Pain Relief)Neurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812537037127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812537037127008125370371278125370371270812537037127

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive device battery chargerAn electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to the battery of a noninvasive device to recharge it for operation; it is not intended to receive data from and transmit data to other devices (i.e., not a transceiver). It is typically in the form of an electronic circuitry housing with a cable.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
1-800-618-3402Info@nalumed.com

Regulatory Flags#

DUNS number
067140761
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812537030562Nalu Medical, Inc.72004-US720042020-04-21
00812537030081Nalu Medical, Inc.13001-US130012020-04-21
00812537037752Nalu™ User Trial Kit740222026-05-27
10812537030057Nalu Medical, Inc.12001-060-US12001-060-US2020-04-21
10812537030064Nalu Medical, Inc.12002-030-US12002-030-US2020-04-21
10812537030071Nalu Medical, Inc.12006-060-US12006-060-US2020-04-21
10812537030095Nalu Medical, Inc.23001-045-US23001-045-US2020-04-21
10812537030101Nalu Medical, Inc.23001-060-US23001-060-US2020-04-21
10812537030118Nalu Medical, Inc.23002-045-US23002-045-US2020-04-21
10812537030125Nalu Medical, Inc.23002-065-US23002-065-US2020-04-21
10812537030132Nalu Medical, Inc.23003-045-US23003-045-US2020-04-21
10812537030149Nalu Medical, Inc.23003-060-US23003-060-US2020-04-21
10812537030163Nalu Medical, Inc.23005-US23005-US2020-04-21
10812537030194Nalu Medical, Inc.23012-030-US23012-030-US2020-04-21
10812537030200Nalu Medical, Inc.23012-045-US23012-045-US2020-04-21
10812537030217Nalu Medical, Inc.23012-065-US23012-065-US2020-04-21
10812537030224Nalu Medical, Inc.23013-050-US23013-050-US2020-04-21
00812537030050Nalu Medical, Inc.12001-060-US12001-060-US2020-04-21
00812537030067Nalu Medical, Inc.12002-030-US12002-030-US2020-04-21
00812537030074Nalu Medical, Inc.12006-060-US12006-060-US2020-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812537030234Therapy DiscNALU MEDICAL, INC.GZB2026-01-19
00812537030234Therapy DiscNALU MEDICAL, INC.GZF2026-01-19
00812537032399Therapy DiscNALU MEDICAL, INC.GZF2026-01-19
00812537032399Therapy DiscNALU MEDICAL, INC.GZB2026-01-19
00812537032917Nalu Medical, Inc.NALU MEDICAL, INC.GZF2022-09-30
00812537030630Nalu Medical, Inc.NALU MEDICAL, INC.GZF2021-12-10
00812537031910Nalu Medical, Inc.NALU MEDICAL, INC.GZF2021-12-10
00812537032986Nalu Medical, Inc.NALU MEDICAL, INC.GZF2021-12-10
00812537033303Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-08-20
00812537030050Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
00812537030050Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
00812537030067Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
00812537030067Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
00812537030074Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
00812537030074Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
00812537030098Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
00812537030098Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
00812537030104Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
00812537030104Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
00812537030111Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
00812537030111Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
00812537030128Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
00812537030128Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
00812537030135Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
00812537030135Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
00812537030142Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
00812537030142Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
00812537030166Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21
00812537030166Nalu Medical, Inc.NALU MEDICAL, INC.GZF2020-04-21
00812537030203Nalu Medical, Inc.NALU MEDICAL, INC.GZB2020-04-21