FDA.reportPublic FDA data

Puritan Opti-Swab

Primary DI
30609576900892
Brand
Puritan Opti-Swab
Company
Puritan Medical Products
Model
CB-206 (25-3506-H)
Catalog number
CB-206 (25-3506-H)
Device description
Puritan Fecal Opti-Swab Collection & Transport System
Published
2022-12-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JSMCulture Media, Non-Propagating Transport

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50609576900896PackageGS16Not in Commercial Distribution
30609576900892PrimaryGS10
00609576900892Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5060957690089650609576900896
3060957690089230609576900892
00609576900892006095769008926095769008920609576900892

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose absorbent tip applicator/swab, single-useA hand-held manual device, also known as a cotton bud or swab, in the form of a stick with a single- or double-ended absorbent tip (e.g., cotton pledget), intended for cleaning or applying a substance (e.g., medication) to a superficial wound or body orifice, and/or to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is intended for use in a healthcare setting and/or in the home. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
800-321-2313sales@puritanmedproducts.com

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
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
30609576900137Puritan Opti-SwabLA-116 (3316-H)LA-116 (3316-H)2022-12-08
30609576900144Puritan Opti-SwabLA-117 (3317-H)LA-117 (3317-H)2022-12-08
30609576900151Puritan Opti-SwabLA-106 (3506-H)LA-106 (3506-H)2022-12-08
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16973471962171BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
16973471962188BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
16973471962195BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
16973471962201BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
16973471962218BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
16973471962225BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
16973471962232BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
16973471962249BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
16973471962256BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
16973471962263BioSciShenzhen Dakewe Bio-engineering Co., LtdJSM2026-05-08
00810164510815Atida Viral Transport Medium (Non-inactivated Type)ACESO LABORATORIES INC.JSM2026-03-23
38053326011826BD FCTCOPAN ITALIA SPAJSM2026-01-26
38053326009557Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPAJSM2025-05-28
38053326009861Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPAJSM2025-05-28
38053326010287Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPAJSM2025-05-28
38053326010447Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPAJSM2025-05-28
38053326011079Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPAJSM2025-05-28
38053326011185Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPAJSM2025-05-28
58053326010403Copan Universal Transport Medium (UTM-RT) SystemCOPAN ITALIA SPAJSM2025-05-28
38053326011710UriSponge™COPAN ITALIA SPAJSM2025-03-12
38053326011598UTM®COPAN ITALIA SPAJSM2024-11-13
38053326011604UTM® COPAN ITALIA SPAJSM2024-11-13
38053326011611UTM® COPAN ITALIA SPAJSM2024-11-13
00816576026067TransPROHARDY DIAGNOSTICSJSM2024-10-08
16977644780029BioSci™Shenzhen Dakewe Bio-engineering Co., LtdJSM2024-08-30
16977644780036BioSci™Shenzhen Dakewe Bio-engineering Co., LtdJSM2024-08-30
16977644780043BioSci™Shenzhen Dakewe Bio-engineering Co., LtdJSM2024-08-30
16977644780012BioSci™Shenzhen Dakewe Bio-engineering Co., LtdJSM2024-08-12
16973471969941BioSci™Shenzhen Dakewe Bio-engineering Co., LtdJSM2024-07-23
16973471969996BioSci™Shenzhen Dakewe Bio-engineering Co., LtdJSM2024-07-23