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
00609576381164Puritan®25-806 2WC TT FDNA25-806 2WC TT FDNA2026-07-31
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
30609576901943Puritan® UniTranz-RT®UT-300 RBUT-300 RB2026-07-31
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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