FDA.reportPublic FDA data

Tablo(R) Straws

Primary DI
10850001011164
Brand
Tablo(R) Straws
Company
OUTSET MEDICAL, INC.
Model
PN-0004378
Catalog number
PN-0004467, PN-0005451
Device description
Straws, for concentrate bottles
Published
2020-08-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
10850001011164PackageGS112In Commercial Distribution
20850001011161PackageGS148In Commercial Distribution
00850001011167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000101116410850001011164
2085000101116120850001011161
00850001011167008500010111678500010111670850001011167

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
844.698.2256TechnicalService@outsetmedical.com

Regulatory Flags#

DUNS number
788744477
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
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
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
00850001011105Tablo Hemodialysis ConcentratePN-0002630A-1252020-08-03
20850001011024Tablo StrawsPN-0000503ST-1002015-11-03
00850001011006Tablo Hemodialysis ConsolePN-00008502015-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09551019761686VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-30
09555793107623VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-30
09555793107630VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-30
09555793107647VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-30
09555793107654VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-30
09555793107661VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-30
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
09551032478011STREAMLINEVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793100891VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793100907VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793100921VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793100938VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793100945VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793100969VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793100976VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793100983VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793100990VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793101003VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793107524VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793107531VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793107548VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793107555VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793107562VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793107579VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793107586VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793107593VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23
09555793107609VITALVITAL HEALTHCARE SDN. BHD.FJK2026-10-23