FDA.reportPublic FDA data

Tablo Hemodialysis Concentrate

Primary DI
00850001011105
Brand
Tablo Hemodialysis Concentrate
Company
Outset Medical, Inc.
Model
PN-0002630
Catalog number
A-125
Device description
Liquid acid concentrate, 45X, 1K, 2.5Ca, 1 U.S. gallon
Published
2020-08-03
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
FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FJKSet, Tubing, Blood, With And Without Anti-Regurgitation ValveGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190793000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190793000Tablo Hemodialysis System, Tablo CartridgeOutset Medical, Inc.2019-12-12KDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850001011102PackageGS14In Commercial Distribution
00850001011105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000101110210850001011102
00850001011105008500010111058500010111050850001011105

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Avoid freezing or storage in excessive heat.
Storage Environment Temperature40 Degrees Fahrenheit90 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
844.698.2256TechnicalService@outsetmedical.com

Regulatory Flags#

DUNS number
788744477
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850001011303TabloCart™ with Prefiltration DrawerPN-0006813PN-00069882024-05-17
00850001011204Tablo(R) Hemodialysis SystemPN-0006000PN-00070012020-06-17
00850001011273Tablo(R) CartridgePN-0004220PN-00068272024-01-22
00850001011266Tablo(R) Hemodialysis SystemPN-00070002025-09-21
00850001011341Tablo(R) Hemodialysis SystemPN-00070012025-09-21
00850001011358Tablo(R) Hemodialysis SystemPN-00060012025-09-21
00850001011044Tablo Hemodialysis ConcentratePN-0000832A-2252016-01-29
00850001011051Tablo Hemodialysis ConcentratePN-0000833A-3252016-01-29
00850001011075Tablo CartridgePN-0002305CART-2002017-04-11
00850001011136Tablo(R) StrawsPN-00042112020-08-03
00850001011167Tablo(R) StrawsPN-0004378PN-0004467, PN-00054512020-08-03
00850001011174Tablo(R) Disinfectant StrawsPN-0004681PN-00046752020-08-03
00850001011211Tablo(R) CartridgePN-0005643PN-00042202022-04-11
10850001011218Tablo(R) CartridgePN-0005643PN-00042202022-04-11
00850001011242Tablo(R) CartridgePN-0006310PN-00042202022-04-11
00850001011259Tablo(R) CartridgePN-0006887PN-00042202024-05-21
00850001011297TabloCart™ with Prefiltration DrawerPN-00069882024-05-17
20850001011024Tablo StrawsPN-0000503ST-1002015-11-03
00850001011006Tablo Hemodialysis ConsolePN-00008502015-10-23
00850001011013Tablo CartridgeDWG-3008CART-1002015-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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09555793107678VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-30
09555793107685VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-30
09555793107616VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-27
09551032478004STREAMLINEVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
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09555793100891VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
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09555793100983VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
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09555793101003VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793107524VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793107531VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
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09555793107555VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
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09555793107579VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
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09555793107593VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
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