FDA.reportPublic FDA data

Tablo(R) Straws

Primary DI
10850001011133
Brand
Tablo(R) Straws
Company
OUTSET MEDICAL, INC.
Model
PN-0004211
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
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
10850001011133PackageGS150In Commercial Distribution
00850001011136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000101113310850001011133
00850001011136008500010111368500010111360850001011136

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis dialysate tubing, single-useA sterile length of flexible tube, typically made of synthetic polymer material(s), intended to deliver haemodialysis dialysate and/or haemodialysis dialysate components (water, haemodialysis concentrate) to and/or from a haemodialysis machine/system. This is a single-use device.

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
false
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
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
00850001011303TabloCart™ with Prefiltration DrawerPN-00068132024-05-17
00850001011204Tablo(R) Hemodialysis SystemPN-00060002020-06-17
00850001011273Tablo(R) CartridgePN-0008544PN-00042202024-01-22
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
06948082774904NovaLineBain Medical Equipment (Guangzhou) Co., Ltd.FJK2026-06-04
06948082700729DORABain Medical Equipment (Guangzhou) Co., Ltd.FJK2026-05-13
04711552764666SUNDERSUNDER BIOMEDICAL TECH. CO., LTD.FJK2026-04-24
04711552760026SUNDERSUNDER BIOMEDICAL TECH. CO., LTD.FJK2026-04-23
04711552761498SUNDERSUNDER BIOMEDICAL TECH. CO., LTD.FJK2026-04-23
04711552764048SUNDERSUNDER BIOMEDICAL TECH. CO., LTD.FJK2026-04-23
04711552764086SUNDERSUNDER BIOMEDICAL TECH. CO., LTD.FJK2026-04-23
04711552764758SUNDERSUNDER BIOMEDICAL TECH. CO., LTD.FJK2026-04-23
08859915300017N/ATIANYI MEDICAL(THAILAND) LIMITEDFJK2026-01-01
008408611025185008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
008408611025255008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
008408611025325008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
008408611025565008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
008408611025635008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
008408611026005008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
008408611026245008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
108408611025155008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
108408611025225008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
108408611025395008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
108408611025535008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
108408611025605008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
108408611026075008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
108408611026215008XFresenius Medical Care Renal Therapies Group, LLCFJK2025-08-01
00860008016942Moda-flx Hemodialysis SystemDiality IncFJK2025-07-16
00860008016973Moda-flx Hemodialysis SystemDiality IncFJK2025-07-16
00860008016904Moda-flx Hemodialysis SystemDiality IncFJK2025-07-16
00860008016911Moda-flx Hemodialysis SystemDiality IncFJK2025-07-16
00860008016928Moda-flx Hemodialysis SystemDiality IncFJK2025-07-16
00860008016959Moda-flx Hemodialysis SystemDiality IncFJK2025-07-16
00860008016966Moda-flx Hemodialysis SystemDiality IncFJK2025-07-16