AMSafe® Pre-Filled Normal Saline Flush Syringe

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref IVF1205SSKRef IVF2020SSRef IVF1005SSKRef IVF1205SSK2Ref IVF1203SSRef IVF2020SSKRef IVF2020SSK2Ref IVF1210Ref IVF1210SSRef IVF1210SSKRef IVF1003SSKRef IVF2020Ref IVF1010SSRef IVF1205SSRef IVF1010SSKRef IVF1203SSK2

by Amsino International, Inc.

Identity

Trade Name: AMSafe® Pre-Filled Normal Saline Flush Syringe EUDAMEDFDA UDI
AMSafe ® Pre-Filled Normal Saline Flush Syringe FDA UDI
Generic Name: Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial FDA UDI
Device Name: Pre-Filled Normal Saline Flush Syringe EUDAMED
AMSafe® Pre-Filled Normal Saline Flush Syringe 0.9% Sodium Chloride Injection, USP Sterile Field Ready Preservative Free FDA UDI
AMSafe® Pre-Filled Normal Saline Flush Syringe 0.9% Sodium Chloride Injection, USP Sterile Fluid & Path Do Not Place Syringe on a Sterile Field 20 mL Fill • Preservative Free FDA UDI
3mL FDA UDI
10mL FDA UDI
AMSafe® Pre-Filled Normal Saline Flush Syringe 0.9% Sodium Chloride Injection, USP Sterile Fluid & Path Do Not Place Syringe on a Sterile Field 10 mL Fill • Preservative Free FDA UDI
5mL FDA UDI
Pre-Filled Normal Saline Flush Syringe, 10 ml 0.9% Sodium Chloride Injection, USP, poly blister package, Sterile Field Ready, Gamma radiation sterilization FDA UDI
Model / Reference: IVF1205SSK EUDAMED
IVF2020SS EUDAMED
IVF1005SSK EUDAMED
IVF1205SSK2 EUDAMED
IVF1203SS EUDAMED
IVF2020SSK EUDAMED
IVF2020SSK2 EUDAMED
IVF1210 EUDAMED
IVF1210SS EUDAMED
IVF1210SSK EUDAMED
IVF1003SSK EUDAMED
IVF2020 EUDAMED
IVF1010SS EUDAMED
IVF1205SS EUDAMED
IVF1010SSK EUDAMED
IVF1203SSK2 EUDAMED
1 FDA UDI
Description: AMSafe® Pre-Filled Normal Saline Flush Syringe 0.9% Sodium Chloride Injection, USP Sterile Field Ready Preservative Free FDA UDI
AMSafe® Pre-Filled Normal Saline Flush Syringe 0.9% Sodium Chloride Injection, USP Sterile Fluid & Path Do Not Place Syringe on a Sterile Field 20 mL Fill • Preservative Free FDA UDI
3mL FDA UDI
10mL FDA UDI
AMSafe® Pre-Filled Normal Saline Flush Syringe 0.9% Sodium Chloride Injection, USP Sterile Fluid & Path Do Not Place Syringe on a Sterile Field 10 mL Fill • Preservative Free FDA UDI
5mL FDA UDI
Pre-Filled Normal Saline Flush Syringe, 10 ml 0.9% Sodium Chloride Injection, USP, poly blister package, Sterile Field Ready, Gamma radiation sterilization FDA UDI

Identifiers

Catalog Number: IVF1205SS FDA UDI
IVF1210SS FDA UDI
IVF1203SS FDA UDI
IVF2020SS FDA UDI
IVF2020 FDA UDI
IVF1003SSK FDA UDI
IVF1010SSK FDA UDI
IVF1210 FDA UDI
IVF1005SSK FDA UDI
IVF1010SS FDA UDI
Primary DI / UDI-DI: 00704411009989 EUDAMEDFDA UDI
00704411009996 EUDAMEDFDA UDI
00704411009972 EUDAMEDFDA UDI
00704411010008 EUDAMEDFDA UDI
00704411009965 EUDAMEDFDA UDI
10704411017707 EUDAMEDFDA UDI
10704411017615 EUDAMEDFDA UDI
00704411009958 EUDAMEDFDA UDI
10704411017714 EUDAMEDFDA UDI
00704411013092 EUDAMED
00704411013825 EUDAMED
00704411013115 EUDAMED
00704411015591 EUDAMED
00704411013108 EUDAMED
00704411013528 EUDAMED
00704411013818 EUDAMED
30704411013529 FDA UDI
Basic UDI-DI: B-00704411013092 EUDAMED
B-00704411010008 EUDAMED
B-10704411017714 EUDAMED
B-00704411013825 EUDAMED
B-00704411009972 EUDAMED
B-00704411013115 EUDAMED
B-00704411015591 EUDAMED
B-00704411009958 EUDAMED
B-00704411009996 EUDAMED
B-00704411013108 EUDAMED
B-10704411017707 EUDAMED
B-00704411009965 EUDAMED
B-00704411013528 EUDAMED
B-00704411009989 EUDAMED
B-10704411017615 EUDAMED
B-00704411013818 EUDAMED
510(k) Number: K183473 FDA UDI
FDA Product Code: NGT FDA UDI
EMDN Code: A02010701 PREFILLED SYRINGES WITH STERILE PHYSIOLOGICAL SOLUTION EUDAMED
GMDN Term: Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 880.5200 FDA UDI
Market of Registration: Netherlands EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDIFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial

AMSafe® Pre-Filled Normal Saline Flush Syringe by Amsino International, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED

BAL Flush Spritze 10ml DS — Jiaxing Tianhe Pharmaceutical Co., Ltd. · Class IIa
Pre-fillefd flush syringe(B001-MY) — Jiangsu Embrace Science&Technology Development Co., Ltd. · Class IIa
Burg Pharma — Jiangsu Caina Medical Co.,Ltd. · Class IIa
BAL Flush Spritze 5ml SS — Jiaxing Tianhe Pharmaceutical Co., Ltd. · Class IIa
Pre-Filled Saline Flush Syringe, Sterile, 5mL — Dynarex Corp. · Class II
Halyard — OWENS & MINOR DISTRIBUTION, INC. · Class II
EASY FLUSH — SPM MEDICARE PVT, LTD. · Class IIb
Prefilled Syringe with 0.9% Saline Solution — Poly Medicure Limited · Class IIb

Cleared under the same submission

K183473 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Amsino International, Inc.

Sources (26)

FDA UDI 60b0f96d-e852-4c0a-8aec-748a6bfbf94f 35 fields · synced Aug 4, 2026
FDA UDI ae3a3fd7-d272-445a-9473-e6c89435b352 35 fields · synced May 29, 2026
FDA UDI b7f02a15-dadf-424e-a312-ef0ca9422092 35 fields · synced May 30, 2026
FDA UDI 505cf7bb-8aff-4fb8-ad5c-da6c0c91934f 35 fields · synced May 30, 2026
FDA UDI 40e7bbc9-af09-4a1b-9653-8ffed9c498b9 35 fields · synced May 30, 2026
FDA UDI 8eb238fc-7758-4d08-9be8-5738e28ba3c9 35 fields · synced May 30, 2026
FDA UDI c185aab5-fbd6-4a2e-996c-2204f2e049ac 35 fields · synced May 30, 2026
FDA UDI fd6f987f-b34b-4a22-b01b-8c98ee2b4c8d 35 fields · synced May 30, 2026
FDA UDI 60e83b56-c7a6-4c79-89d1-fd40874ddcb9 35 fields · synced May 30, 2026
FDA UDI deaa3e7d-008e-4267-8ff7-a046221beb00 36 fields · synced May 30, 2026
EUDAMED f707b0e2-43a0-4154-af36-e77c9213a3db 61 fields · synced Jul 8, 2026
EUDAMED b653dfba-c38e-488e-87db-8ed0d757a007 61 fields · synced Jul 9, 2026
EUDAMED d6c9ff61-8849-4986-b2de-2cac13f21cff 61 fields · synced Jul 9, 2026
EUDAMED 342452d7-83d8-4d16-bfa0-566f446dc5d9 61 fields · synced Jul 12, 2026
EUDAMED e707ba56-a6f4-43c3-ad7d-55fdd14b39be 61 fields · synced Jul 12, 2026
EUDAMED 64c3aa70-5345-45dc-9500-2241a1109fb9 61 fields · synced Jul 15, 2026
EUDAMED 1352d00c-6149-4082-9c03-132c4d756120 61 fields · synced Jul 16, 2026
EUDAMED 7705b285-b0a8-4c07-91a6-ec469edc6735 61 fields · synced Jul 17, 2026
EUDAMED 6bba5cbb-f81c-468d-9210-d6c03cf518c7 61 fields · synced Jul 17, 2026
EUDAMED 1dcc21d9-33e3-4e44-98cc-87d137a2b620 61 fields · synced Jul 21, 2026
EUDAMED 0549c445-b001-419b-9e48-b5d28871d88a 61 fields · synced Jul 23, 2026
EUDAMED 6726aa07-6706-469c-9a6a-3870d7cea521 61 fields · synced Jul 28, 2026
EUDAMED 8766eabc-7bc3-4ef6-9468-6f6a385e011f 61 fields · synced Jul 28, 2026
EUDAMED a0b776d1-bc1a-4e85-9d97-ea9b0f4289a5 61 fields · synced Jul 29, 2026
EUDAMED b528f73c-6137-4bdf-8d4a-285ddfcf1417 61 fields · synced Aug 4, 2026
EUDAMED c3629c74-c56e-4059-a1c3-3cd211dee6db 61 fields · synced Aug 4, 2026

AMSafe® Pre-Filled Normal Saline Flush Syringe

Identity

Identifiers

Classification

Clinical & Handling

Similar devices

Cleared under the same submission

Authorization Coverage (2 countries)

Regulatory Authorizations

Manufacturer

Sources (26)