FDA.reportPublic FDA data

UNIVERSAL SYRINGE TIP ADAPTER

Primary DI
00810080610002
Brand
UNIVERSAL SYRINGE TIP ADAPTER
Company
MPS Pharma & Medical, Inc.
Model
18B
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
10810080610009PackageGS150In Commercial Distribution
00810080610002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081008061000910810080610009
00810080610002008100806100028100806100020810080610002

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10816336022275NC600300-ENFNEOCHILD, LLCFMF2026-07-23
10816336022282NC602000-ENFNEOCHILD, LLCFMF2026-07-23
10816336022442NC600100-ENFNEOCHILD, LLCFMF2026-07-23
00884450492888Merit Medical®Merit Medical Systems, Inc.FMF2026-07-22
10383017593015Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593213Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593411Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593510Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593718Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844612Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844711Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844919Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
18257200121076O-GENESISOrthofix US LLCFMF2026-07-17
18257200121083O-GENESISOrthofix US LLCFMF2026-07-17
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05391530753951Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754217Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754620Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754699Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754941NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754965NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530753968Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754088Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754194Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754224Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754231Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530753456Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753463Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753487Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01
05391530753517Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-01