FDA.reportPublic FDA data

Excelsior

Primary DI
10363807100913
Brand
Excelsior
Company
MEDLINE INDUSTRIES, INC.
Model
10091-280
Catalog number
10091-280
Device description
Sterile Field Saline Flush
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082837000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082837000STERILE FIELD SALINE PRE-FILLED SYRINGE(S)Excelsior Medical Corp.2008-12-18NGT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20363807100910PackageGS18In Commercial Distribution
10363807100913PrimaryGS10
00363807100916Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2036380710091020363807100910
1036380710091310363807100913
00363807100916003638071009163638071009160363807100916

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter flush syringeA sterile device consisting of a barrel (cylinder) with plunger intended to be used to wash the lumen of a vascular access catheter in situ with a rush of solution to maintain patency. It is prefilled with a saline or low-dose heparin solution, and is typically used when a patient has an intravenous (IV) access device in place. It is not intended for dry product reconstitution, for medication dilution, or where IV therapy with sodium chloride (NaCl) or heparin is indicated. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Total Volume10Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Protect from freezing
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
100
DM exempt
true
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
10888277419452MEDLINEMDTZ1068516ABMDTZ1068516AB2016-10-14
00888277719081RexallDG11009803DG110098032026-06-03
10884389106303MEDLINEDYND20323DYND203232021-01-05
10888277656970MEDLINEDYND50221NSDYND50221NS2021-01-02
10888277656987MEDLINEDYND50223NSDYND50223NS2021-01-02
10888277657007MEDLINEDYND50252NSDYND50252NS2021-01-02
10888277658325MEDLINEOR712NSOR712NS2021-01-02
10888277694507MEDLINEDYND50251NSDYND50251NS2021-01-02
10888277694514MEDLINEDYND50253NS1DYND50253NS12021-01-02
10888277725157MEDLINEEQX2377EQX23772023-12-15
10080196000630Teleflex/Hudson RCI540254022016-04-08
10080196003648Teleflex/Hudson RCI2700-2052700-2052016-04-08
10080196986217Teleflex/Hudson RCI540354032016-04-08
10193489078022NAMICH74904487202H749044872022022-02-24
10812564036022MedlineSYN3000SYN30002026-03-11
10812564036077MedlineSYN3004SYN30042026-03-11
10812564036107MedlineSYN3015SYN30152026-03-11
10812564036183MedlineSYN3020SYN30202026-03-11
10812564036190MedlineSYN3025SYN30252026-03-11
10812564036213MedlineSYN3030SYN30302026-03-11

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