FDA.reportPublic FDA data

TERUMO

Primary DI
14806017506978
Brand
TERUMO
Company
TERUMO (PHILIPPINES) CORPORATION
Model
SS+03L1
Device description
TERUMO Syringes without Needle
Published
2017-01-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K023271000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023271000TERUMO SYRINGE WITH/WITHOUT NEEDLETerumo Medical Corp.2002-12-18FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
34806017506972PackageGS1100In Commercial Distribution
54806017506976PackageGS118In Commercial Distribution
14806017506978PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3480601750697234806017506972
5480601750697654806017506976
1480601750697814806017506978

GMDN Terms#

Term, Definition table
TermDefinition
Metered-delivery hypodermic syringeA sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume3Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not store at extreme temperature and humidity.
Special Storage Condition, Specify00Fragile. Handle with care. Keep dry. Keep away from sunlight. Stacking limit by 4.

Contacts#

Phone, Email table
PhoneEmail
+1(800)283-7866tmccustomer.admin@terumomedical.com

Regulatory Flags#

DUNS number
718848773
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
34806017510146SURFLOSR-OX1451CA2016-09-14
34806017510153SURFLOSR-OX1632CA2016-09-14
34806017510160SURFLOSR-OX1651CA2016-09-14
34806017510177SURFLOSR-OX1664CA2016-09-14
34806017510184SURFLOSR-OX1851CA2016-09-14
34806017510191SURFLOSR-OX1864CA2016-09-14
34806017512225SURFLOSR-OX1464CA2016-09-14
34806017512232SURFLOSR-OX1832CA2016-09-14
34806017512249SURFLOSR-OX2051CA2016-09-14
34806017512256SURFLOSR-OX2032CA2016-09-14
34806017512263SURFLOSR-OX2025CA2016-09-14
34806017512270SURFLOSR-OX2225CA2016-09-14
34806017512287SURFLOSR-OX2419CA2016-09-14
14806017506992SURGUARD2SG2+18252017-02-06
14806017507005SURGUARD2SG2+18382017-02-28
14806017507012SURGUARD2SG2+19252017-02-28
14806017507029SURGUARD2SG2+19382017-02-28
14806017507036SURGUARD2SG2+20252017-02-28
14806017507043SURGUARD2SG2+20382017-02-28
14806017507050SURGUARD2SG2+21252017-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05391530754170polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754255polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754279polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
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
10192253070804MonojectCardinal Health 200, LLCFMF2026-09-21
M992MTINS01291271MedThermalCarelife (usa) Inc.FMF2026-09-18
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00850091070242CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
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00850091070419CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070426CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070433CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
06976523540238Sterile Insulin Syringes with needles for single useShandong Caremed Medical Products Co.,LtdFMF2026-08-26
06976523540245Sterile Insulin Syringes with needles for single useShandong Caremed Medical Products Co.,LtdFMF2026-08-26
06976523540252Sterile Insulin Syringes with needles for single useShandong Caremed Medical Products Co.,LtdFMF2026-08-26
00193982458119INSTAFILLGLOBUS MEDICAL, INC.FMF2026-08-14