FDA.reportPublic FDA data

Ceros

Primary DI
00810192690121
Brand
Ceros
Company
Rhino Medical Supply Inc
Model
RM-PF1203
Catalog number
RM-PF1203
Device description
CerosFLUSH IV Flush Syringe, USP Normal Saline, 3 mL in a 12 mL Syringe, 400/cs
Published
2025-11-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NGTSaline, Vascular Access Flush

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150143000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150143000Normal Saline FlushNurse Assist, Inc.2015-08-31NGT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810192690121PackageGS1100In Commercial Distribution
00810192690138PackageGS14In Commercial Distribution
00810192690114PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810192690121008101926901218101926901210810192690121
00810192690138008101926901388101926901380810192690138
00810192690114008101926901148101926901140810192690114

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
Total Volume3Milliliter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117524559
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850060997983CerosRM-SN122705RM-SN1227052026-02-23
10850060997980CerosRM-SN122705RM-SN1227052026-02-23
00850041572444CerosRM-SN121815RM-SN1218152026-01-27
00850041572536CerosRM-SN122310RM-SN1223102026-01-27
00850060997952CerosRM-SN122510RM-SN1225102026-01-27
00850060997969CerosRM-SN122515RM-SN1225152026-01-27
00850060997976CerosRM-SN122558RM-SN1225582026-01-27
10850041572441CerosRM-SN121815RM-SN1218152026-01-27
10850041572533CerosRM-SN122310RM-SN1223102026-01-27
10850060997959CerosRM-SN122510RM-SN1225102026-01-27
10850060997966CerosRM-SN122515RM-SN1225152026-01-27
10850060997973CerosRM-SN122558RM-SN1225582026-01-27
00850060997440CerosRM-SN15BRM-SN15B2024-03-18
00850060997457CerosRM-SN15DRM-SN15D2024-03-19
00850060997464CerosRM-SN15ERM-SN15E2024-03-19
00850060997433CerosRM-SN15ARM-SN15A2024-03-18
00810192690114CerosRM-PF1203RM-PF12032025-11-18
00810192690619CerosRM-PF1210SFRM-PF1210SF2025-11-18
00810192690701CerosRM-CST1410RM-CST14102025-11-18
00810192690053CerosRM-PF1210RM-PF12102025-11-18

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
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
06971564464574ITL BiomedicalJiangsu Caina Medical Co.,LtdNGT2025-05-14