Amxor VacFlush Pre-Filled Normal Saline Flush Syringe

GUDID 10850049248065

AMXOR VASCFLUSH Pre-Filled Normal Saline Syringe is a pre-filled syringe with saline (0.9% sodium chloride injection, NaCl) and are used to help prevent vascular access systems from becoming blocked and to help remove any medication that may be left at the catheter site.

Amxor Healthcare LLC

Irrigation syringe Irrigation syringe Irrigation syringe Irrigation syringe Irrigation syringe Irrigation syringe Irrigation syringe Irrigation syringe Irrigation syringe Irrigation syringe Irrigation syringe Irrigation syringe Irrigation syringe Irrigation syringe Irrigation syringe Irrigation syringe Irrigation syringe Irrigation syringe
Primary Device ID10850049248065
NIH Device Record Keya72b1fe8-164e-456b-adb4-d6d5de09bb81
Commercial Distribution StatusIn Commercial Distribution
Brand NameAmxor VacFlush Pre-Filled Normal Saline Flush Syringe
Version Model NumberAVF-10
Company DUNS124112849
Company NameAmxor Healthcare LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone7867861207
Emaile.colon@amxorhealthcare.com
Phone7867861207
Emaile.colon@amxorhealthcare.com
Phone7867861207
Emaile.colon@amxorhealthcare.com
Phone7867861207
Emaile.colon@amxorhealthcare.com
Phone7867861207
Emaile.colon@amxorhealthcare.com
Phone7867861207
Emaile.colon@amxorhealthcare.com
Phone7867861207
Emaile.colon@amxorhealthcare.com
Phone7867861207
Emaile.colon@amxorhealthcare.com
Phone7867861207
Emaile.colon@amxorhealthcare.com
Phone7867861207
Emaile.colon@amxorhealthcare.com
Phone7867861207
Emaile.colon@amxorhealthcare.com
Phone7867861207
Emaile.colon@amxorhealthcare.com
Phone7867861207
Emaile.colon@amxorhealthcare.com
Phone7867861207
Emaile.colon@amxorhealthcare.com
Phone7867861207
Emaile.colon@amxorhealthcare.com
Phone7867861207
Emaile.colon@amxorhealthcare.com
Phone7867861207
Emaile.colon@amxorhealthcare.com
Phone7867861207
Emaile.colon@amxorhealthcare.com

Device Dimensions

Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter

Device Identifiers

Device Issuing AgencyDevice ID
GS100850049248068 [Primary]
GS110850049248065 [Package]
Contains: 00850049248068
Package: Box [40 Units]
In Commercial Distribution
GS120850049248062 [Package]
Package: Case [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NGTSaline, Vascular Access Flush

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-15
Device Publish Date2024-03-07

Devices Manufactured by Amxor Healthcare LLC

00850049248082 - AMXOR Imperative 3-Layer SMS Jacket2024-03-21 AMXOR Imperative 3-Layer SMS Jacket, Fire-Retardant & Fluid Resistant, Size Small, Pink
00850049248105 - AMXOR Imperative 3-Layer SMS Jacket2024-03-21 AMXOR Imperative 3-Layer SMS Jacket, Fire-Retardant & Fluid Resistant, Size Small, Purple
00850049248129 - AMXOR Imperative 3-Layers SMS Jacket2024-03-21 AMXOR Imperative 3-Layer SMS Jacket, Fire-Retardant & Fluid Resistant, Size Small, Ceil Blue
00850049248143 - AMXOR Imperative 3-Layer SMS Jacket2024-03-21 AMXOR Imperative 3-Layer SMS Jacket, Fire-Retardant & Fluid Resistant, Size Medium, Pink
00850049248167 - AMXOR Imperative 3-Layer SMS Jacket2024-03-21 AMXOR Imperative 3-Layer SMS Jacket, Fire-Retardant & Fluid Resistant, Size Medium, Purple
00850049248181 - AMXOR Imperative 3-Layer SMS Jacket2024-03-21 AMXOR Imperative 3-Layer SMS Jacket, Fire-Retardant & Fluid Resistant, Size Medium, Ceil Blue
00850049248204 - AMXOR Imperative 3-Layer SMS Jacket2024-03-21 AMXOR Imperative 3-Layer SMS Jacket, Fire-Retardant & Fluid Resistant, Size Large, Pink
00850049248228 - AMXOR Imperative 3-Layer SMS Jacket2024-03-21 AMXOR Imperative 3-Layer SMS Jacket, Fire-Retardant & Fluid Resistant, Size Large, Purple

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