FDA.reportPublic FDA data

Aquastat SFR

Primary DI
10859809005047
Brand
Aquastat SFR
Company
MRP, LLC
Model
2S0708
Catalog number
2S0708
Device description
Pre-filled Flush syringe with 0.9% NaCL (saline), 20mL, Sterile Field Ready
Published
2022-12-12
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
NGTSaline, Vascular Access Flush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGTSaline, Vascular Access FlushGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20859809005044PackageGS14In Commercial Distribution
10859809005047PrimaryGS10
00859809005040Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085980900504420859809005044
1085980900504710859809005047
00859809005040008598090050408598090050400859809005040

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobialA solution (e.g., saline, sterile water) intended to flush the lumen of an in situ intravenous access device (IVAD), typically a peripheral intravenous cannula or central venous catheter, to maintain patency; it does not include an anticoagulant or antimicrobial agent. Also known as lock solution, the device is available in a small container (e.g., bottle) or prefilled syringe. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
6158332633CUSTOMERCARE@AQUABILITI.COM

Regulatory Flags#

DUNS number
604012703
Device count
80
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30859809005027Aquastat2T0806-SP2T0806-SP2019-05-23
40859809005024Aquastat2T0806-SP2T0806-SP2019-05-23
10859809005009Aquastat SFR2S07062S07062016-09-23
10859809005016Aquastat2T08052T08052016-09-23
10859809005023Aquastat2T08062T08062016-09-23
10859809005030Aquastat2T08072T08072016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860002238500Piccolo MedicalPiccolo Medical, Inc.NGT2026-05-06
08904379807920Easy FlushSPM MEDICARE PRIVATE LIMITEDNGT2026-03-07
08904379807937Easy FlushSPM MEDICARE PRIVATE LIMITEDNGT2026-03-07
08904379807975Easy FlushSPM MEDICARE PRIVATE LIMITEDNGT2026-03-07
08904379808002Easy FlushSPM MEDICARE PRIVATE LIMITEDNGT2026-03-07
08904379807890Easy FlushSPM MEDICARE PRIVATE LIMITEDNGT2026-03-07
18904379807927Easy FlushSPM MEDICARE PRIVATE LIMITEDNGT2026-03-07
18904379807934Easy FlushSPM MEDICARE PRIVATE LIMITEDNGT2026-03-07
08904379807968Easy FlushSPM MEDICARE PRIVATE LIMITEDNGT2026-03-07
01890437980797Easy FlushSPM MEDICARE PRIVATE LIMITEDNGT2026-03-07
18904379808009Easy FlushSPM MEDICARE PRIVATE LIMITEDNGT2026-03-07
00850063139472Neil Medical Group Neil Medical GroupNGT2025-12-08
00810192690114CerosRhino Medical Supply IncNGT2025-11-18
00810192690619CerosRhino Medical Supply IncNGT2025-11-18
00810192690053CerosRhino Medical Supply IncNGT2025-11-18
00810192690084CerosRhino Medical Supply IncNGT2025-11-18
00810192690121CerosRhino Medical Supply IncNGT2025-11-18
00810192690626CerosRhino Medical Supply IncNGT2025-11-18
00382903065929PosiFlushBECTON, DICKINSON AND COMPANYNGT2025-11-03
20612479279258McKessonMCKESSON MEDICAL-SURGICAL INC.NGT2025-10-03
20612479279289McKessonMCKESSON MEDICAL-SURGICAL INC.NGT2025-10-03
10704411017615AMSafe® Pre-Filled Normal Saline Flush SyringeAMSINO INTERNATIONAL, INC.NGT2025-06-23
10704411017707AMSafe® Pre-Filled Normal Saline Flush SyringeAMSINO INTERNATIONAL, INC.NGT2025-06-23
10704411017714AMSafe® Pre-Filled Normal Saline Flush SyringeAMSINO INTERNATIONAL, INC.NGT2025-06-23
30704411017619AMSafe® Pre-Filled Normal Saline Flush SyringeAMSINO INTERNATIONAL, INC.NGT2025-06-23
30704411017701AMSafe® Pre-Filled Normal Saline Flush SyringeAMSINO INTERNATIONAL, INC.NGT2025-06-23
30704411017718AMSafe® Pre-Filled Normal Saline Flush SyringeAMSINO INTERNATIONAL, INC.NGT2025-06-23
06971564461122GBUKJiangsu Caina Medical Co.,LtdNGT2025-05-14
06971564461139GBUKJiangsu Caina Medical Co.,LtdNGT2025-05-14
06971564464567ITL BiomedicalJiangsu Caina Medical Co.,LtdNGT2025-05-14