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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
50609576900896PackageGS16In Commercial Distribution
30609576900892PrimaryGS10
00609576900891Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5060957690089650609576900896
3060957690089230609576900892
00609576900891006095769008916095769008910609576900891

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 Temperature-2 Degrees Celsius25 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
001101419
Device count
50
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10609576330763Puritan HydraFlock25-3806-H BT25-3806-H BT2022-12-08
10609576330770Puritan PurFlock Ultra25-3806-U BT25-3806-U BT2022-12-08
10609576330787Puritan PurFlock Ultra25-3316-H BT25-3316-H BT2022-12-08
10609576330794Puritan PurFlock Ultra25-3316-U BT25-3316-U BT2022-12-08
10609576330800Puritan HydraFlock25-3317-H BT25-3317-H BT2022-12-08
10609576330916Puritan HydraFlock25-3316-H EMB 80 BT25-3316-H EMB 80 BT2022-12-08
10609576330923Puritan HydraFlock25-3316-H EMB 100 BT25-3316-H EMB 100 BT2022-12-08
10609576330930Puritan PurFlock Ultra25-3316-U EMB 80 BT25-3316-U EMB 80 BT2022-12-08
10609576331166Puritan HydraFlock25-3706-H BT PK25-3706-H BT PK2022-12-08
10609576331197Puritan HydraFlock25-3206-H 20MM BT25-3206-H 20MM BT2022-12-08
10609576331241Puritan HydraFlock25-3319-H BT25-3319-H BT2022-12-08
10609576331340Puritan HydraFlock25-3806-H BT PK25-3806-H BT PK2022-12-08
10609576370783Puritan PurFlock Ultra25-3706-U BT25-3706-U BT2022-12-08
10609576381710Puritan25-1506 1PF BT BL25-1506 1PF BT BL2022-12-08
30609576900007Puritan UniTranz-RTUT-100UT-1002022-12-08
30609576900014Puritan UniTranz-RTUT-300UT-3002022-12-08
30609576900021Puritan UniTranz-RTUT-106UT-1062022-12-08
30609576900038Puritan UniTranz-RTUT-116UT-1162022-12-08
30609576900045Puritan UniTranz-RTUT-117UT-1172022-12-08
30609576900052Puritan UniTranz-RTUT-306UT-3062022-12-08

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