FDA.reportPublic FDA data

GBUK

Primary DI
16971564461136
Brand
GBUK
Company
Jiangsu Caina Medical Co.,Ltd
Model
10mL
Catalog number
PFS-10SSU
Device description
10 ml SP Prefilled saline syringe 0.9%Sodium Chloride(0.9%Na Cl)
Published
2025-05-14
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
K220060000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220060000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16971564461136PackageGS130In Commercial Distribution
26971564461133PackageGS1480In Commercial Distribution
36971564461130PackageGS11In Commercial Distribution
06971564461139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697156446113616971564461136
2697156446113326971564461133
3697156446113036971564461130
06971564461139069715644611396971564461139

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544543513
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971564461696ITLITL 100012026-09-30
06971564461702ITLITL 100022026-09-30
46971564464336CAINA"21Gx3/4"""2026-04-14
46971564464343CAINA1mL2026-04-14
06971564465021CAINA25501CA2552020-09-20
06971564465038CAINA25701CA2572020-09-20
06971564465045CAINA323501CA32352020-09-20
06971564465052CAINA325501CA32552020-09-20
06971564465069CAINA125501CA12552020-09-20
06971564465076CAINA123501CA12352020-09-20
06971564465083CAINA320501CA32052020-09-20
06971564465090CAINA322701CA32272020-09-20
06971564465106CAINA25G*5/8-01CA2532020-11-10
06971564465113CAINA1ml LL 30G*1/2-01CA13022020-11-10
06971564465120CAINA3ml LL 21G*1-01CA32152020-11-10
06971564465137CAINA3ml LL 22G*1-01CA32252020-11-10
06971564465144CAINA3ml LL 25G*5/8-01CA32532020-11-10
06971564465151CAINA325502CN32552020-12-01
06971564465175CAINA3ml LL 23G*1-02CN323102021-01-15
06971564465182CAINA3ml LL 23G*1.5-02CN323152021-01-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00682686005403AMSafe SP 0.9% NaClMedxl IncNGT2026-07-29
10682686005295Praxiject SP 0.9% NaClMedxl IncNGT2026-07-29
09347144017688Metier MedicalMETIER MEDICAL LTDNGT2026-06-29
09347144017695Metier MedicalMETIER MEDICAL LTDNGT2026-06-29
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