FDA.reportPublic FDA data

Puritan

Primary DI
00609576370021
Brand
Puritan
Company
Puritan Medical Products
Model
25-705
Catalog number
25-705
Device description
Sterile Infant Tongue Depressors
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
FMADepressor, Tongue, Non-Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMADepressor, Tongue, Non-SurgicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30609576370022PackageGS1100In Commercial Distribution
50609576370026PackageGS110In Commercial Distribution
00609576370021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3060957637002230609576370022
5060957637002650609576370026
00609576370021006095763700216095763700210609576370021

GMDN Terms#

Term, Definition table
TermDefinition
Tongue depressor, examination, single-useA hand-held device used to displace the tongue to facilitate examination of the surrounding organs/tissues. It is typically a double-ended flat device with rounded working ends made of wood or plastic materials; it may be aromatic/flavoured to make then less intrusive. The device may be used in a healthcare facility, doctor's office, or in the home. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
001101419
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00609576360251Puritan® Dry Transport System Sterile Flocked Collection Device25-3606-U BT25-3606-U BT2026-05-29
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M2207250003Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.FMA2025-09-11
M220769000Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.FMA2025-09-11
M220770001Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.FMA2025-09-11
05010058083608InstrapacROBINSON HEALTHCARE LIMITEDFMA2025-09-11
05010058183605InstrapacROBINSON HEALTHCARE LIMITEDFMA2025-09-11
M220720005Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.FMA2025-09-11
M220769003Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.FMA2025-09-11
M220770003Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.FMA2025-09-11
10080196158744MEDLINEMEDLINE INDUSTRIES, INC.FMA2025-01-17
10080196158768MEDLINEMEDLINE INDUSTRIES, INC.FMA2025-01-17
00887482032756Symmetry WiederASPEN SURGICAL PRODUCTS, INC.FMA2024-08-15
00887482032763Symmetry WiederASPEN SURGICAL PRODUCTS, INC.FMA2024-08-15
00887482049167Symmetry WiederASPEN SURGICAL PRODUCTS, INC.FMA2024-08-15
00887482049174Symmetry WiederASPEN SURGICAL PRODUCTS, INC.FMA2024-08-15
00884392954451Safety 1stDOREL JUVENILE GROUP, INC.FMA2023-10-15
20884392954455Safety 1stDOREL JUVENILE GROUP, INC.FMA2023-10-15
06973069980023Tongue DepressorDalian Rongbang Medical Healthy Devices Co., Ltd.FMA2023-10-04
16973069980020Tongue DepressorDalian Rongbang Medical Healthy Devices Co., Ltd.FMA2023-10-04
00732094082326Welch Allyn, Inc.WELCH ALLYN, INC.FMA2023-08-17
00810132041150HCSConcordance Healthcare Solutions LLCFMA2023-05-12
00810132041167HCSConcordance Healthcare Solutions LLCFMA2023-05-12
00810132041174HCSConcordance Healthcare Solutions LLCFMA2023-05-12
00810132041181HCSConcordance Healthcare Solutions LLCFMA2023-05-12
10810132041157HCSConcordance Healthcare Solutions LLCFMA2023-05-12
10810132041164HCSConcordance Healthcare Solutions LLCFMA2023-05-12
10810132041171HCSConcordance Healthcare Solutions LLCFMA2023-05-12
10810132041188HCSConcordance Healthcare Solutions LLCFMA2023-05-12
04053755114603DISPOSABLE TONGUE BLADEHeine Optotechnik GmbH & Co. KGFMA2023-01-11
04053755114771TONGUE BLADE HOLDERHeine Optotechnik GmbH & Co. KGFMA2022-12-12
04053755114788TONGUE BLADE HOLDER DISPOSABLE BLADEHeine Optotechnik GmbH & Co. KGFMA2022-12-12