FDA.reportPublic FDA data

PurSafe+

Primary DI
00609576901935
Brand
PurSafe+
Company
Puritan Medical Products
Model
PSP-120
Catalog number
PSP-120
Device description
Puritan® PurSafe Plus® Collection and Transport System
Published
2026-07-08
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

Product Codes#

Code, Name table
CodeName
QBDMicrobial Nucleic Acid Storage And Stabilization Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QBDMicrobial Nucleic Acid Storage And Stabilization DeviceMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242820000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242820000Puritan PurSafe Plus Collection and Transport SystemPuritan Medical Products, LLC2025-05-27QBD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00609576901935PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00609576901935006095769019356095769019350609576901935

GMDN Terms#

Term, Definition table
TermDefinition
General specimen collection kitA collection of devices intended exclusively for professional use 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 laboratory analysis [e.g., nucleic acid technique (NAT), microbiological culture, histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered receptacle with or without an additive/medium [e.g., preservation solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)]. This is a single-use device.

Regulatory Flags#

DUNS number
001101419
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
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
00609576390142Puritan25-1503 1PFB SOLID25-1503 1PFB SOLID2026-07-02
00609576010330Puritan25-1506 1PFB25-1506 1PFB2022-12-08
00609576340031Puritan HydraFlock25-3406-H25-3406-H2022-12-08
00609576380037Puritan25-806 1WC25-806 1WC2022-12-08
00609576380105Puritan25-806 1PD25-806 1PD2022-12-08
00609576010132BD Affirm25-806 1PRB BD25-806 1PRB BD2026-07-08
00609576381539Puritan®25-806 1PDS BINAX25-806 1PDS BINAX2026-07-08
00609576381782Puritan®25-806 1PRB 250/10 UNB25-806 1PRB 250/10 UNB2026-07-08
00609576390302Puritan®25-806 1PRB 80/3025-806 1PRB 80/302026-07-08
00609576901515Puritan® OptiSwab®LA-106 USLA-106 US2026-07-08
00609576901713Puritan® OptiSwab®LA-117 BCLA-117 BC2026-07-08
00609576901775Puritan® OptiSwab®LA-106 BCLA-106 BC2026-07-08
00609576901911PurSafe+PSP-106PSP-1062026-07-08
00609576901928PurSafe+PSP-116PSP-1162026-07-08
10609576380362Puritan®25-806 1PDB SLD ABON25-806 1PDB SLD ABON2026-07-08
10609576381413Puritan®25-806 1WC BT25-806 1WC BT2026-07-08
00609576010347Puritan25-1506 1PFB SLD 2025-1506 1PFB SLD 202022-12-08
00609576390180Puritan25-1406 1PF 5025-1406 1PF 502022-12-08
00609576330339Puritan HydraFlock25-3318-H25-3318-H2022-12-08
00609576380143Puritan25-806 1PR25-806 1PR2022-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00609576901911PurSafe+Puritan Medical ProductsQBD2026-07-08
00609576901928PurSafe+Puritan Medical ProductsQBD2026-07-08
06974679160201ZHEJIANG GENE SCIENCEZHEJIANG GENE SCIENCE CO., LTD.QBD2026-05-11
06974679160768ZHEJIANG GENE SCIENCEZHEJIANG GENE SCIENCE CO., LTD.QBD2026-05-11
10850045030008Magbio Genomics, Inc.Magbio Genomics, Inc.QBD2026-03-27
00850049735490Magbio Genomics, Inc.Magbio Genomics, Inc.QBD2026-03-27
00850045030018Magbio Genomics, Inc.Magbio Genomics, Inc.QBD2026-03-27
B9030201PrimeStore MTMLonghorn Vaccines And Diagnostics, LLCQBD2025-11-03
B9030315PrimeStore MTM Longhorn Vaccines And Diagnostics, LLCQBD2025-11-03
07898996204648Molecular Transport Media (MTM) 2mlA. L. B. LUZQBD2024-08-29
07898996204655Molecular Transport Media (MTM) 3mlA. L. B. LUZQBD2024-08-29
05411967003464InActiv BlueFertipro NVQBD2024-08-14
05411967003471InActiv BlueFertipro NVQBD2024-08-14
06973843228914Sample Preservative FluidHangzhou Bioer Technology Co., Ltd.QBD2024-07-15
16973471968784DTPMShenzhen Dakewe Bio-engineering Co., LtdQBD2024-06-07
26973471968781DTPMShenzhen Dakewe Bio-engineering Co., LtdQBD2024-06-07
06973471968763DTPMShenzhen Dakewe Bio-engineering Co., LtdQBD2024-05-20
B90305154PrimeStore MTMLonghorn Vaccines And Diagnostics, LLCQBD2024-03-20
B9030515500PrimeStore MTMLonghorn Vaccines And Diagnostics, LLCQBD2024-03-20
B90305153PrimeStore MTMLonghorn Vaccines And Diagnostics, LLCQBD2024-02-27
B90305151000PrimeStore MTMLonghorn Vaccines And Diagnostics, LLCQBD2024-02-27
B90312023PrimeStore MTMLonghorn Vaccines And Diagnostics, LLCQBD2024-02-09
B90312033PrimeStore MTMLonghorn Vaccines And Diagnostics, LLCQBD2024-02-09
B90305151PrimeStore MTMLonghorn Vaccines And Diagnostics, LLCQBD2024-02-07
B90312022PrimeStore MTMLonghorn Vaccines And Diagnostics, LLCQBD2024-02-07
B90312032PrimeStore MTMLonghorn Vaccines And Diagnostics, LLCQBD2024-02-07
B903051550PrimeStore MTMLonghorn Vaccines And Diagnostics, LLCQBD2024-02-07
B90312002100PrimeStore MTMLonghorn Vaccines And Diagnostics, LLCQBD2024-02-07
B9031203100PrimeStore MTMLonghorn Vaccines And Diagnostics, LLCQBD2024-02-07
06973471968503BioSci™Shenzhen Dakewe Bio-engineering Co., LtdQBD2024-02-01