FDA.reportPublic FDA data

Puritan® OptiSwab®

Primary DI
00609576901713
Brand
Puritan® OptiSwab®
Company
Puritan Medical Products
Model
LA-117 BC
Catalog number
LA-117 BC
Device description
Puritan® OptiSwab® Liquid Aimes Collection & 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
true
Single use
true

Product Codes#

Code, Name table
CodeName
JTWSystem, Transport, Aerobic
JTXTransport Systems, Anaerobic
LIODevice, Specimen Collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JTWSystem, Transport, AerobicMicrobiology1
JTXTransport Systems, AnaerobicMicrobiology1
LIODevice, Specimen CollectionMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120846000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120846000TRANSPORT CULTURE MEDIUM DEVICEPuritan Medical Products, LLC2012-06-08LIO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00609576901713PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00609576901713006095769017136095769017130609576901713

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
00609576901775Puritan® OptiSwab®LA-106 BCLA-106 BC2026-07-08
00609576901911PurSafe+PSP-106PSP-1062026-07-08
00609576901928PurSafe+PSP-116PSP-1162026-07-08
00609576901935PurSafe+PSP-120PSP-1202026-07-08
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
00609576901515Puritan® OptiSwab®Puritan Medical ProductsJTX2026-07-08
00609576901515Puritan® OptiSwab®Puritan Medical ProductsJTW2026-07-08
00609576901515Puritan® OptiSwab®Puritan Medical ProductsLIO2026-07-08
00609576901775Puritan® OptiSwab®Puritan Medical ProductsLIO2026-07-08
00609576901775Puritan® OptiSwab®Puritan Medical ProductsJTX2026-07-08
00609576901775Puritan® OptiSwab®Puritan Medical ProductsJTW2026-07-08
00884999051690simpli-COLLECTABBOTT MOLECULAR INC.LIO2026-04-13
38053326011826BD FCTCOPAN ITALIA SPALIO2026-01-26
05060441760036binx ioBINX HEALTH LIMITEDLIO2025-09-03
05060441760043binx ioBINX HEALTH LIMITEDLIO2025-09-03
15060441760033binx ioBINX HEALTH LIMITEDLIO2025-09-03
15060441760040binx ioBINX HEALTH LIMITEDLIO2025-09-03
00848838066665Amies Clear Gel,Single Swab PK/500REMEL, INC.LIO2025-06-18
00848838066672Amies Clear Gel,Single Swab PK/50REMEL, INC.LIO2025-06-18
00848838066689Amies Clear Gel,Dual Swab PK/500REMEL, INC.LIO2025-06-18
00848838066696Amies Clear Gel,Dual Swab PK/50REMEL, INC.LIO2025-06-18
00848838066702Amies Clear Gel,Wire Shaft Swab PK/100REMEL, INC.LIO2025-06-18
00848838066719Amies Clear Gel,Wire Shaft PK/50REMEL, INC.LIO2025-06-18
00848838066757Amies Charcoal Gel,Single Swab PK/50REMEL, INC.LIO2025-06-18
00661392055650LSL HEALTHCARELSL Industries, LLCJTW2025-06-06
38053326009557Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPALIO2025-05-28
38053326009861Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPALIO2025-05-28
38053326010287Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPALIO2025-05-28
38053326010447Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPALIO2025-05-28
38053326011079Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPALIO2025-05-28
38053326011185Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPALIO2025-05-28
58053326010403Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPALIO2025-05-28
38053326011710UriSponge™COPAN ITALIA SPALIO2025-03-12
00840165400303Starswab II Bacteriology Culture Collection and Transport SystemPretium Canada Packaging ULCLIO2025-02-21
00840165400327Starswab II Bacteriology Culture Collection and Transport SystemPretium Canada Packaging ULCLIO2025-02-21