FDA.reportPublic FDA data

Blood Pressure Cuff

Primary DI
04039361207960
Brand
Blood Pressure Cuff
Company
Fresenius Medical Care AG
Model
F40016610
Device description
BPM cuff, 340 to 500 mm, size L
Published
2025-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KDIDialyzer, High Permeability With Or Without Sealed Dialysate System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDIDialyzer, High Permeability With Or Without Sealed Dialysate SystemGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150708000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K1507080002008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis MachineFresenius Medical Care Renal Therapies Group, LLC2015-12-10KDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04039361207960PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04039361207960040393612079604039361207960

GMDN Terms#

Term, Definition table
TermDefinition
Blood pressure cuff, reusableA band-like device that has an inflatable bladder in an inelastic sleeve with one or two connecting tubes with connector (typically locking connectors) that can be connected to a mechanism for inflating and deflating the bladder and/or a sphygmomanometer or a patient monitoring device/system that is used to determine a patient's blood pressure. It is wrapped around the upper arm or the leg (thigh) of the patient. This is a reusable device which may be intended for single-patient or multi-patient reuse.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length340Millimeter
Length500Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1 (800) 227-2572xx@xx.xx

Regulatory Flags#

DUNS number
324661834
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04039361261313DIASAFE®plusUSF00013010F000130102026-05-01
04039361259150FX CorALF000129692026-01-02
04039361259570FX CorALF000129702026-01-02
04039361259594FX CorALF000129712026-01-02
04039361259617FX CorALF000129732026-01-02
04039361259631FX CorALF000129742026-01-02
04039361259655FX CorALF000129752026-01-02
04039361259938FX CorALF000129722026-01-02
04039361259167FX CorALF000129692026-01-02
04039361259587FX CorALF000129702026-01-02
04039361259600FX CorALF000129712026-01-02
04039361259624FX CorALF000129732026-01-02
04039361259648FX CorALF000129742026-01-02
04039361259662FX CorALF000129752026-01-02
04039361259945FX CorALF000129722026-01-02
008408611028605008XM2044112025-08-01
008408611028775008XM2044212025-08-01
008408611028845008XM2044312025-08-01
04039361207953Blood Pressure CuffF400166112025-08-01
04039361208073Blood Pressure CuffF400166092025-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07332414200183RevaclearVantive Health GmbHKDI2026-05-29
00842289103764EXPRESS FLUID WARMERNXSTAGE MEDICAL, INC.KDI2026-04-29
00842289103719VersiHDNXSTAGE MEDICAL, INC.KDI2026-04-22
08056992333543HPH-700 HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333550HPH-700TS HEMOCONCENTRATMEDICA SPAKDI2026-04-01
08056992333567HPH-400 HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333574HPH-1000 HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333581HPH-1400 HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333598HPH-400TS HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333604HPH-1000TS HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333611HPH-1400TS HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333628HPH JUNIORMEDICA SPAKDI2026-04-01
04039361259150FX CorALFresenius Medical Care AGKDI2026-01-02
04039361259570FX CorALFresenius Medical Care AGKDI2026-01-02
04039361259594FX CorALFresenius Medical Care AGKDI2026-01-02
04039361259617FX CorALFresenius Medical Care AGKDI2026-01-02
04039361259631FX CorALFresenius Medical Care AGKDI2026-01-02
04039361259655FX CorALFresenius Medical Care AGKDI2026-01-02
04039361259938FX CorALFresenius Medical Care AGKDI2026-01-02
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04987671030214Filter for dialysate purificationNIKKISO CO.,LTD.KDI2025-04-07
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