FDA.reportPublic FDA data

iProElite Cart

Primary DI
07290016681147
Brand
iProElite Cart
Company
FORMATK SYSTEMS LTD
Model
FS10001-3
Catalog number
FS10001-3
Device description
Cart to be used with Formatk Systems Ltd Forma, iProElite
Published
2024-10-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)Anesthesiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160195000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160195000Forma System, Forma Light SystemFormatk Systems , Ltd.2016-04-15ONF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016681147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016681147072900166811477290016681147

GMDN Terms#

Term, Definition table
TermDefinition
Electromechanical device/system transport trolleyA mobile (on wheels) cart intended to be used as a carrier for transporting an electromechanical device(s) or a powered system assembly. This trolley (cart) may be designed specifically for a proprietary control unit/system, and will typically have one or more horizontal surfaces where the devices are placed; it may include additional features (e.g., gas cylinder holder, intravenous pole) specific to a proprietary system. Neither electromechanical devices nor system components are included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
532396673
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290016681314PLGFS10009FS100092017-08-18
07290016681093iProEliteFS10000-3FS10000-32024-10-15
07290016681086Sheerwave PlusIPLaser 360FS700202023-08-27
07290016681079DioBreezeFS80020FS800202021-06-25
07290016681031Magma SparkFS80000FS800002016-11-30
07290016681000FormaFS10000FS100002017-08-18
07290016681024MagmaFS70000FS700002017-08-18
07290016681048Magma Spark ProFS90000FS900002018-12-16
07290016681055Magma Spark PlusFS90000FS900002018-12-16
07290016681062AlphaFS90000FS900002018-12-16
07290016681130DioBreeze CartFS80023FS800232021-06-25
07290016681437HR-MiniFS80021FS800212021-06-25
07290016681444HR-MaxFS80022FS800222021-06-25
07290016681321ALDFS70001FS700012017-08-18
07290016681338NDFS70002FS700022017-08-18
07290016681345LLDFS70007FS70072017-08-18
07290016681017Forma LightFS60000FS600002017-08-18
07290016681123Magma Spark CartFS80001FS800012018-12-16
07290016681352S-430FS90011FS900112018-12-16
07290016681369S-530FS90012FS900122018-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840178704955ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178704962ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178704979ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178704986ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178704993ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705006ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705013ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705020ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705037ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705044ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705051ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705068ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705075ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705082ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705099ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705105ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705112ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705129ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705136ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705143ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705150ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705167ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705174ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705181ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705198ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705204ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705211ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178705235ITDTouchpoint Medical, Inc.BZN2026-10-15
00840178704863ITDTouchpoint Medical, Inc.BZN2026-08-03
00840178704122ITDTouchpoint Medical, Inc.BZN2026-07-07