FDA.reportPublic FDA data

Puritan® UniTranz-RT®

Primary DI
30609576901943
Brand
Puritan® UniTranz-RT®
Company
Puritan Medical Products
Model
UT-300 RB
Catalog number
UT-300 RB
Device description
Puritan® UniTranz-RT® Transport System
Published
2026-07-31
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

Product Codes#

Code, Name table
CodeName
JSMCulture Media, Non-Propagating Transport
LIODevice, Specimen Collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSMCulture Media, Non-Propagating TransportMicrobiology1
LIODevice, Specimen CollectionMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113249000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113249000TRANSPORT CULTURE MEDIUM DEVICEPuritan Medical Products, LLC2012-03-01JSM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50609576901947PackageGS16In Commercial Distribution
30609576901943PrimaryGS10
00609576901942Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5060957690194750609576901947
3060957690194330609576901943
00609576901942006095769019426095769019420609576901942

GMDN Terms#

Term, Definition table
TermDefinition
General specimen container IVD, additive/mediumA covered receptacle containing an additive and/or medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, anaerobic, viral transport/inactivation medium)] intended to be used for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for in vitro diagnostic investigation [e.g., nucleic acid technique (NAT), microbiological culture, histopathology]. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.

Regulatory Flags#

DUNS number
001101419
Device count
50
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
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10609576801294Hospital®803-WC HOSPITAL803-WC HOSPITAL2026-07-31
10609576901789QuickVue25-1506 1PFB TT 2017125-1506 1PFB TT 201712026-07-31
30609576380618Hospital®25-806 2WC HOSPITAL25-806 2WC HOSPITAL2026-07-31
00609576381119Puritan®25-806 2PC YELLOW25-806 2PC YELLOW2026-07-27
00609576381133Puritan®25-806 2PC PINK25-806 2PC PINK2026-07-27
00609576381423Puritan®25-806 1PD BT25-806 1PD BT2026-07-27
00609576381676Puritan®25-806 10WCL25-806 10WCL2026-07-27
00609576901799Puritan®25-806 2PC WHITE25-806 2PC WHITE2026-07-27
30609576381196Puritan®25-806 2PR TT25-806 2PR TT2026-07-27
50609576700274Puritan®711-FS711-FS2026-07-27
00609576010378BD ProbeTec25-44135725-4413572026-07-02
00609576700095Puritan®710 CHERRY710 CHERRY2026-07-20
00609576700101Puritan®710 STRAWBERRY710 STRAWBERRY2026-07-20
00609576700118Puritan®710 GRAPE710 GRAPE2026-07-20
10609576150064Puritan®1506-PFB DM1506-PFB DM2026-07-20
10609576300018Puritan® PurFlock Ultra®3000-U E303000-U E302026-07-20
10609576330657Puritan® PurFlock Ultra®3316-U EMB 79MM RING3316-U EMB 79MM RING2026-07-20
10609576330725Puritan® PurFlock Ultra®3806-U EMB 79.5MM3806-U EMB 79.5MM2026-07-20
10609576331098Puritan® PurFlock Ultra®3406-U RING PRT3406-U RING PRT2026-07-20

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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