FDA.reportPublic FDA data

ELISIO™-HX

Primary DI
00383790011815
Brand
ELISIO™-HX
Company
NIPRO MEDICAL CORPORATION
Model
ELISIO™-21HX
Catalog number
DD+ELISIO-21HX
Device description
Hemodialyzer with expanded solute removal profile (up to 45 kDa); Surface area: 2.1m²
Published
2026-08-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QAXHemodialyzer With Expanded Solute Removal Profile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QAXHemodialyzer With Expanded Solute Removal ProfileGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40383790011813PackageGS124In Commercial Distribution
00383790011815PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4038379001181340383790011813
00383790011815003837900118153837900118150383790011815

GMDN Terms#

Term, Definition table
TermDefinition
Hollow-fibre haemodialysis dialyser, single-useA filter that functions as an artificial kidney and typically used in a haemodialysis system to remove impurities/fluid from the blood of a patient. It typically consists of cylindrical containers with thousands of longitudinally arranged hollow-fibre capillary tubes (e.g., polymer, modified cellulose) through which the blood flows. The tube walls function as a semi-permeable membrane, permitting passage of larger molecules from the blood to the dialysate on the outside of the tubes for removal. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Area/Surface Area0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not store at extreme temperature and/or humidity, avoid direct exposure to sunlight and vibrations.

Contacts#

Phone, Email table
PhoneEmail
(908) 393-7030info@nipromed.com

Regulatory Flags#

DUNS number
797372554
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
true
Expiration date on label
true
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
00383790011785ELISIO™-HXELISIO™-15HXDD+ELISIO-15HX2026-08-03
00383790011792ELISIO™-HXELISIO™-17HXDD+ELISIO-17HX2026-08-03
00383790011808ELISIO™-HXELISIO™-19HXDD+ELISIO-19HX2026-08-03
00383790011839PRESSONETRG001-000-000-0012026-05-01
00383790012478relasyringe SYPR-03GA-WPSYPR-03GA-WP6; SYPR-03GA-WP602026-05-01
00383790012515relasyringe SYPR-03GA-WP-S-USSYPR-03GA-WP6-S-US; SYPR-03GA-WP60-S-US2026-05-01
00383790008037Nipro SafeTouch NeedleSAH+1825-1M2026-04-30
00383790008105Nipro SafeTouch NeedleSAH+2138-1M2026-04-30
00383790008136Nipro SafeTouch NeedleSAH+2238-1M2026-04-30
00383790012379Blood pressure cuff for SURDIAL DX Hemodialysis SystemHXA-GCUFF-SRA2025-12-19
00383790012386Blood pressure cuff for SURDIAL DX Hemodialysis SystemHXA-GCUFF-MRA2025-12-19
00383790012393Blood pressure cuff for SURDIAL DX Hemodialysis SystemHXA-GCUFF-LRA2025-12-19
00383790012409Blood pressure cuff for SURDIAL DX Hemodialysis SystemHXA-GCUFF-XLRA2025-12-19
00383790012416Blood pressure cuff hose for SURDIAL DX Hemodialysis SystemHXA-CUFFH-GR35R2025-12-19
40383790012377Blood pressure cuff for SURDIAL DX Hemodialysis SystemHXA-GCUFF-SRA2025-12-19
40383790012384Blood pressure cuff for SURDIAL DX Hemodialysis SystemHXA-GCUFF-MRA2025-12-19
40383790012391Blood pressure cuff for SURDIAL DX Hemodialysis SystemHXA-GCUFF-LRA2025-12-19
40383790012407Blood pressure cuff for SURDIAL DX Hemodialysis SystemHXA-GCUFF-XLRA2025-12-19
40383790012414Blood pressure cuff hose for SURDIAL DX Hemodialysis SystemHXA-CUFFH-GR35R2025-12-19
00383790004503NIPRO TP-SURETPSURE+12015-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00383790011785ELISIO™-HXNIPRO MEDICAL CORPORATIONQAX2026-08-03
00383790011792ELISIO™-HXNIPRO MEDICAL CORPORATIONQAX2026-08-03
00383790011808ELISIO™-HXNIPRO MEDICAL CORPORATIONQAX2026-08-03
07332414125721THERANOVAGambro Dialysatoren GmbHQAX2020-10-26
37332414125722THERANOVAGambro Dialysatoren GmbHQAX2020-10-26
07332414125714THERANOVAGambro Dialysatoren GmbHQAX2020-09-02
37332414125715THERANOVAGambro Dialysatoren GmbHQAX2020-09-02