FDA.reportPublic FDA data

Tile-T20

Primary DI
10850038691117
Brand
Tile-T20
Company
Tasso Inc.
Model
PN0583-02
Published
2025-02-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NNKContainer, Specimen Mailer And Storage, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNKContainer, Specimen Mailer And Storage, Non-SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850038691117PackageGS160In Commercial Distribution
20850038691114PackageGS120In Commercial Distribution
30850038691111PackageGS1100In Commercial Distribution
00850038691110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003869111710850038691117
2085003869111420850038691114
3085003869111130850038691111
00850038691110008500386911108500386911100850038691110

GMDN Terms#

Term, Definition table
TermDefinition
Dried blood spot collection receptacle IVDA self-contained, pen-like device intended to be used by a healthcare professional at the point-of-care, or by a patient/layperson outside a clinical environment, to collect and contain a dried blood spot specimen for subsequent diagnostic testing or screening. The proximal end includes internal capillary tubes which draw the blood specimen into the device, where it is deposited onto one or multiple dried blood collection paper disc(s). It does not contain needles or a lancet. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature18 Degrees Celsius28 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-257-2370customerservice@tassoinc.com

Regulatory Flags#

DUNS number
078431936
Device count
1
DM exempt
false
Premarket exempt
true
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
00850038691158Tasso+K1040-012025-05-13
10850038691155Tasso+K1040-012025-05-13
00850038691011Tasso+ Convenience KitK1019-012022-10-21
00850038691028Tasso+ Convenience KitK1019-022022-10-21
00850038691035Tasso+ Convenience KitK1019-032022-10-21
00850038691042Tasso+ Convenience KitK1019-042022-10-21
00860006434557Tasso+ Convenience KitK1016-042021-12-21
00860006434564Tasso+ Convenience KitK1016-032021-12-21
00860006434571Tasso+ Convenience KitK1016-012021-12-21
00860006434588Tasso+ Convenience KitK1016-022021-12-21
00860006434595Tasso+K1015-012021-12-21
00850038691141Tasso MiniK1037-012025-03-07
10850038691148Tasso MiniK1037-012025-03-07
00850038691004Tasso+K1013-012022-10-21
00850038691134Tasso MiniK1027-012024-08-16
00850038691110Tile-T20PN0583-022025-02-06
00860006434540Tasso-M20K1001-022021-07-20
00860006434502Tasso+ Convenience KitK1011-022021-05-10
00860006434519Tasso+ Convenience KitK1011-032021-05-10
00860006434526Tasso+ Convenience KitK1011-012021-05-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G669CNPTLN1Crow's Nest Biopsy Catchment System, Gen II Twist Lock version, Non-SterileCorramedical Inc.NNK2026-04-07
00860013988029500 Single strip cards and 500 foil-LifelineADVANCE DX, INC.NNK2026-03-03
00860013988036500 Blood Collection Card (500 Double strip cards and 500 foil-Lifeline)ADVANCE DX, INC.NNK2026-03-03
00860013988043Advance Dx 100 Blood Collection Card (single strip cards and 100 foil)ADVANCE DX, INC.NNK2026-03-03
00860013988050Advance Dx 500 Blood Collection Card (500 single strip cards and 500 foil)ADVANCE DX, INC.NNK2026-03-03
00860013988067Advance Dx Blood Collection Card: Single strip cards - no lines on the frontADVANCE DX, INC.NNK2026-03-03
00860013988074Advance Dx Blood Collection Card: Double Strip cardsADVANCE DX, INC.NNK2026-03-03
00860013988098Advance Dx Blood Collection Card: Double-Double Strip cardsADVANCE DX, INC.NNK2026-03-03
00827989007772Health Care Logistics, Inc®Health Care Logistics, Inc.NNK2025-12-19
00827989007789Health Care Logistics, Inc®Health Care Logistics, Inc.NNK2025-12-19
00827989007796Health Care Logistics, Inc®Health Care Logistics, Inc.NNK2025-12-19
B24280EZEX21000Easy 2 Stool Extraction DeviceAMERICAN LABORATORY PRODUCTS COMPANY, LTD.NNK2025-10-30
00810185250004TherapakTherapak LLCNNK2025-08-11
00810185250042TherapakTherapak LLCNNK2025-08-11
00810185250202TherapakTherapak LLCNNK2025-08-11
00810185250349TherapakTherapak LLCNNK2025-08-11
00810185250608TherapakTherapak LLCNNK2025-08-11
00810185250646TherapakTherapak LLCNNK2025-08-11
00810185250561TherapakTherapak LLCNNK2025-08-04
00810185250622TherapakTherapak LLCNNK2025-08-04
00840216128729QUEST DIAGNOSTICS Asp Global, LLCNNK2025-05-27
00840216128736QUEST DIAGNOSTICS Asp Global, LLCNNK2025-05-27
04038917086318Urine receptacle 500mlSarstedt Aktiengesellschaft & Co.KGNNK2025-05-19
00860013899264Paternity Test Kit 50Ditek Consulting, LLCNNK2025-05-06
00860013899288Paternity Test Kit 25Ditek Consulting, LLCNNK2025-05-06
00860011770268Covid 19 Testing KitDitek Consulting, LLCNNK2025-05-01
00613647027059FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.NNK2025-04-30
00613647027066FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.NNK2025-04-30
00613647027073FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.NNK2025-04-30
00613647027080FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.NNK2025-04-30