FDA.reportPublic FDA data

Acid connector guide 1 Gal

Primary DI
00084086113021
Brand
Acid connector guide 1 Gal
Company
Fresenius Medical Care Renal Therapies Group, LLC
Model
F50044953
Device description
Acid connector guide 1 Gal
Published
2025-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K243505000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K2435050005008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC2025-05-30KDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00084086113021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00084086113021000840861130210840861130210084086113021

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis system, institutionalAn assembly of mains electricity (AC-powered) devices intended to be used to perform patient haemodialysis, a treatment whereby extracorporeal blood is passed through a filter to allow for the removal of toxins and/or the replacement of electrolytes, by trained professionals in a healthcare facility. The system functions with dialysate solution and a haemodialysis dialyser (haemodialyzer) for the transfer of substances by diffusion, osmosis and ultrafiltration. It typically includes a pump and tubing to circulate blood through the haemodialysis dialyser, a solution mixer to prepare the dialysate, a monitor with system controls, and other dedicated components.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
079732391
Device count
1
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
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
008408611023655008X HDF Hemodialysis Blood Tubing Set03-5100-72024-04-08
008408611023725008X HDF Hemodialysis Blood Tubing Set with CLiC Blood Chamber03-5100-7C2024-04-08
008408611023895008X HDF Hemodialysis Blood Tubing Set with Access Flow Reversing Connector (Tw03-5150-22024-04-08
00840861102396CitraSure™28-0600-02024-04-04
008408611026245008X04-3000-92025-08-01
00840861103010Acid connector cpl 10L jugF500449502025-08-01
00840861103027Acid connector guide 1 GalF500449532025-08-01
00840861103058BicarbyRFP-404-W2025-12-18
00840861103065BicarbyRFP-453-W2025-12-18
00840861103072BicarbyRFP-454-W2025-12-18
00840861103089BicarbyRFP-456-W2025-12-18
00840861103096BicarbyRFP-403-W2025-12-18
00840861103102BicarbyRFP-403-G2025-12-18
00840861103119BicarbyRFP-453-G2025-12-18
00840861103126BicarbyRFP-454-G2025-12-18
10840861103055BicarbyRFP-404-W2025-12-18
10840861103062BicarbyRFP-453-W2025-12-18
10840861103079BicarbyRFP-454-W2025-12-18
10840861103086BicarbyRFP-456-W2025-12-18
10840861103093BicarbyRFP-403-W2025-12-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07332414202422PRISMAFLEX ST60 SETVantive Health GmbHKDI2026-10-23
07332414202439PRISMAFLEX ST100 SETVantive Health GmbHKDI2026-10-23
07332414202446PRISMAFLEX ST150 SETVantive Health GmbHKDI2026-10-23
07332414124731TherMaxVantive Health GmbHKDI2026-10-21
07332414126018PrismaxVantive Health GmbHKDI2026-10-21
04039361273590multiFluxFresenius Medical Care Holdings, Inc.KDI2026-09-29
04039361273613multiFluxFresenius Medical Care Holdings, Inc.KDI2026-09-29
07332414202309TherMaxVantive Health GmbHKDI2026-07-06
08056992333536HEMOCOR HPH MINI - PEDIATRICMEDICA SPAKDI2026-07-06
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
00383790012379Blood pressure cuff for SURDIAL DX Hemodialysis SystemNIPRO MEDICAL CORPORATIONKDI2025-12-19
00383790012386Blood pressure cuff for SURDIAL DX Hemodialysis SystemNIPRO MEDICAL CORPORATIONKDI2025-12-19