FDA.reportPublic FDA data

BULK, NON-STERILE UNIVERSAL SYRINGE TIP ADAPTER

Primary DI
00810080610026
Brand
BULK, NON-STERILE UNIVERSAL SYRINGE TIP ADAPTER
Company
MPS Pharma & Medical, Inc.
Model
18B-B
Published
2022-08-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K894217000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K894217000SYRINGE TIP ADAPTORAcacia, Inc.1989-09-12FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810080610023PackageGS1500In Commercial Distribution
00810080610026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081008061002310810080610023
00810080610026008100806100268100806100260810080610026

GMDN Terms#

Term, Definition table
TermDefinition
Medication transfer setA collection of sterile devices and supplies designed to transfer parenteral medications, and sometimes intravenous (IV) fluids, between a first container(s) [e.g., a vial(s)] and a second container [e.g., an intravenous (IV) bag]; it may also be used to reconstitute medication for its preparation and administration. It is available in a variety of configurations and typically includes tubes, connectors, spike(s), syringes, and caps. This is a single-use device.

Regulatory Flags#

DUNS number
117970217
Device count
1
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
00810080612525OptiDropper®, SafeFill™UA15-415-50-TRAY-15CR2026-05-14
00810080612532OptiDropper®, SafeFill™UA15-415-109-TRAY-5-WHT2026-05-14
00810080612549OptiDropper®UA15-415-10-BOT-52026-05-14
00810080612556OptiDropper®UA15-415-10-BOT-5-WHT2026-05-14
00810080612563SAFEFILL™UA15-415-50-TRAY-10-WHT2026-05-14
00810080612518CONNECTOR LUER FEMALE/MALEPLS616082025-11-07
00810080612501OptiDropper®, SafeFill™UA15-415-109-TRAY-52025-10-22
00810080612495OptiDropper®, SafeFill™UA15-415-50-TRAY-102025-08-19
10810080612492OptiDropper®, SafeFill™UA15-415-50-TRAY-102025-08-19
00810080612488OptiDropper®UA15-415-50-BOT-10BRW2025-08-15
10810080612485OptiDropper®UA15-415-50-BOT-10BRW2025-08-15
00810080612464OptiDropper®UA15-415-108-TRAY-72025-07-19
10810080612461OptiDropper®UA15-415-108-TRAY-72025-07-19
00810080612372OptiDropper™ AC211633-122025-05-13
10810080612379OptiDropper™ AC211633-122025-05-13
00810080612327OptiDropper™AC211631-22025-05-12
00810080612334OptiDropper™ AC211631-3002025-05-12
00810080612341OptiDropper™ AC211632-12025-05-12
00810080612358OptiDropper™AC211632-122025-05-12
00810080612365OptiDropper™AC211633-12025-05-12

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Primary DI, Brand, Company table
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05391530754286polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754323polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754385polycarbonate syringesDMC MEDICAL LIMITEDFMF2026-09-27
05391530754415polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754477polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754484polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754651polycarbonate syringesDMC MEDICAL LIMITEDFMF2026-09-27
05391530754736polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
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06976523540245Sterile Insulin Syringes with needles for single useShandong Caremed Medical Products Co.,LtdFMF2026-08-26
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00193982458119INSTAFILLGLOBUS MEDICAL, INC.FMF2026-08-14