FDA.reportPublic FDA data

Smeed Technologies

Primary DI
00850059853351
Brand
Smeed Technologies
Company
Smeed Technologies LLC
Model
ST-MERK-TS_A03
Published
2024-07-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FOXStand, Infusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOXStand, InfusionGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850059853351PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850059853351008500598533518500598533510850059853351

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument assist arm system, manually-adjustedA manually-powered/-adjusted device assembly intended to be used to hold, maintain in a desired position, and enable positional adjustment of surgical and/or endoscopic instruments during an endoscopic examination/surgical procedure (i.e., during use). It typically consists of rigid or semi-rigid arms with joints, instrument holding and locking mechanisms, and a clamping mechanism for fixation to a stable object (e.g., the operating table) or is mounted on a mobile (on wheels) base.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
025033708
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850059853009Smeed TechnologiesST-MERK-EVAC-01A_ANZ2024-07-15
00850059853016Smeed TechnologiesST-MERK-01_022024-07-15
00850059853023Smeed TechnologiesST-MERK-TS_A042024-07-15
00850059853030Smeed TechnologiesST-MERK-02_04_AV2024-07-15
00850059853047Smeed TechnologiesST-MERK-01_0112024-07-15
00850059853054Smeed TechnologiesST-MERK-01_032024-07-15
00850059853061Smeed TechnologiesST-MERK-01A_01A2024-07-15
00850059853078Smeed TechnologiesST-MERK-AT-012024-07-15
00850059853085Smeed TechnologiesST-MERK-TXBAR-01_ANZ2024-07-15
00850059853092Smeed TechnologiesST-MERK-BR-01_ANZ2024-07-15
00850059853108Smeed TechnologiesST-MERK-TT-01_ANZ2024-07-15
00850059853115Smeed TechnologiesST-MERK-TS-360-01_ANZ2024-07-15
00850059853122Smeed TechnologiesST-MERK-3N1-01_ANZ2024-07-15
00850059853139Smeed TechnologiesST-MERK-ES_01_ANZ2024-07-15
00850059853146Smeed TechnologiesST-MERK-TS-FIXED-01_ANZ2024-07-15
00850059853153Smeed TechnologiesST-MERK-AV-01_MIL_20_ANZ2024-07-15
00850059853160Smeed TechnologiesST-MERK-TX-02B_ANZ2024-07-15
00850059853177Smeed TechnologiesST-MERK-AT-01_MIL_20_ANZ2024-07-15
00850059853184Smeed TechnologiesST-MERK-01_05U2024-07-15
00850059853191Smeed TechnologiesST-MERK-01_042024-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00761887005464PryorPRYOR PRODUCTSFOX2026-05-26
00810050863469AeroSled Transport Deck (TD)LIFEPORT, LLCFOX2026-05-26
00810050863476AeroSled Transport Deck (TD)LIFEPORT, LLCFOX2026-05-26
00761887005419PryorPRYOR PRODUCTSFOX2026-05-25
00761887005433PryorPRYOR PRODUCTSFOX2026-05-25
00761887005440Connected RockPRYOR PRODUCTSFOX2026-05-25
00761887005457CorCytePRYOR PRODUCTSFOX2026-05-25
00761887005426PryorPRYOR PRODUCTSFOX2026-05-21
00810050863445Patient Loading Utility System (PLUS)LIFEPORT, LLCFOX2026-05-15
00810050863452Patient Loading Utility System (PLUS)LIFEPORT, LLCFOX2026-05-15
00810050863414Pole MountLIFEPORT, LLCFOX2026-04-28
00810050863421Pole MountLIFEPORT, LLCFOX2026-04-28
B458205997000HVP CartThe Wells Johnson CompanyFOX2026-04-20
B458205998000Wells Johnson Hymen CartThe Wells Johnson CompanyFOX2026-04-20
00810050863407Load RampLIFEPORT, LLCFOX2026-04-17
09420012405890Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDFOX2026-04-08
09420012409690Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDFOX2026-04-08
09420012416728Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDFOX2026-04-08
00810050863391Medical CabinetLIFEPORT, LLCFOX2026-04-07
04260217220158chapot® table System Siemens Artis zee / Q / Q.zenAmtrion GmbHFOX2026-03-30
04260217220196chapot® table System Siemens ARTIS pheno / iconoAmtrion GmbHFOX2026-03-30
09420012405999Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDFOX2026-03-26
09420012406019Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDFOX2026-03-26
09420012405913Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDFOX2026-03-23
09420012425805Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDFOX2026-03-18
09420012426871Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDFOX2026-03-18
09420012433961Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDFOX2026-03-18
04061162024637CIM med GmbHCIM med GmbHFOX2026-03-18
04061162042907CIM med GmbHCIM med GmbHFOX2026-03-18
04061162086086CIM med GmbHCIM med GmbHFOX2026-03-18