AMSure® Urethral Self Catheterization Kit 8Fr. AS85008K

GUDID 40704411007556

AMSure® Urethral Self Catheterization Kit 8Fr. with • Pre-lubricated • Closed System CONTENTS STERILIZED USING ETHYLENE OXIDE: 1 each Pre-lubricated PVC Urethral Catheter, 16” (40 cm) Length 1 each 1100 mL Collection Bag with Insertion Tip 1 each Waterproof Underpad, 13”x18” (340 x 450 mm) 1 pair Cuffed Vinyl Gloves 1 each Waste Disposal Bag 1 each Gauze Pad, 4”x4”(100 x 100 mm) NON-STERILE CONTENTS: 1 pack BZK Swabsticks (3) 1 pack Benzalkonium Chloride Prep Pad

AMSINO INTERNATIONAL, INC.

Intermittent urethral catheterization kit
Primary Device ID40704411007556
NIH Device Record Keybfe6d94f-e10c-4d3f-b45d-b494c77c9e56
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMSure® Urethral Self Catheterization Kit 8Fr.
Version Model Number1
Catalog NumberAS85008K
Company DUNS825673239
Company NameAMSINO INTERNATIONAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110704411007555 [Primary]
GS140704411007556 [Package]
Contains: 10704411007555
Package: case [50 Units]
In Commercial Distribution

FDA Product Code

FCMTray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-11-28
Device Publish Date2018-04-28

Devices Manufactured by AMSINO INTERNATIONAL, INC.

40704411016596 - AMSafe ® Pre-Filled Normal Saline Flush Syringe 2023-09-08 AMSafe ® Pre-Filled Normal Saline Flush Syringe, 3mL, use only in flushing compatible intravenous administration sets and indwe
40704411016602 - AMSafe ® Pre-Filled Normal Saline Flush Syringe 2023-09-08 AMSafe ® Pre-Filled Normal Saline Flush Syringe, 5mL, use only in flushing compatible intravenous administration sets and indwe
40704411016619 - AMSafe ® Pre-Filled Normal Saline Flush Syringe2023-09-08 AMSafe ® Pre-Filled Normal Saline Flush Syringe, 10mL, use only in flushing compatible intravenous administration sets and indw
40704411016626 - AMSafe ® Pre-Filled Normal Saline Flush Syringe 2023-09-08 AMSafe ® Pre-Filled Normal Saline Flush Syringe, STERILE FIELD READY, 3mL, use only in flushing compatible intravenous administ
40704411016633 - AMSafe ® Pre-Filled Normal Saline Flush Syringe 2023-09-08 AMSafe ® Pre-Filled Normal Saline Flush Syringe, STERILE FIELD READY, 5mL, use only in flushing compatible intravenous administ
40704411016640 - AMSafe ® Pre-Filled Normal Saline Flush Syringe 2023-09-08 AMSafe ® Pre-Filled Normal Saline Flush Syringe, STERILE FIELD READY, 10mL, use only in flushing compatible intravenous adminis
40704411016244 - AMSafe ® I.V Administration Set 100''2023-08-28 For use with Spectrum, Flo-Gard 6201 and 6301 series pumps 100” (2.5m), 10 drops/mL, Slide and Roller Clamp, 1.2 Micron Filter
40704411016152 - AMSure ® Enteral Administration Kit2023-06-01 Enteral Administration Kit FOR USE WITH AMSure® ENTERAL FEEDING PUMP CONTENTS: -Enteral Feeding 500 mL Bag Pump Set with ENFit

Trademark Results [AMSure]

Mark Image

Registration | Serial
Company
Trademark
Application Date
AMSURE
AMSURE
97706180 not registered Live/Pending
Sensia Inc.
2022-12-06
AMSURE
AMSURE
90788128 not registered Live/Pending
Oil-Dri Corporation of America
2021-06-22
AMSURE
AMSURE
88587246 not registered Live/Pending
AM RE Syndicate Inc.
2019-08-21
AMSURE
AMSURE
87744802 5549732 Live/Registered
Adirondack Trust Company Financial Services, Inc.
2018-01-05
AMSURE
AMSURE
85013272 3919171 Live/Registered
Amsino International, Inc.
2010-04-13
AMSURE
AMSURE
78167962 2736887 Dead/Cancelled
Amsino International, Inc.
2002-09-25
AMSURE
AMSURE
75228668 not registered Dead/Abandoned
Amsino International, Inc.
1997-01-21
AMSURE
AMSURE
73174266 1162165 Dead/Cancelled
Amsure Corporation
1978-06-14

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.