FDA.reportPublic FDA data

TERUMO

Primary DI
54806017507188
Brand
TERUMO
Company
TERUMO (PHILIPPINES) CORPORATION
Model
SS+05L1
Device description
TERUMO Syringes without Needle
Published
2016-12-07
Public version status
Update
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
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
54806017507188PackageGS112In Commercial Distribution
34806017507184PrimaryGS10
14806017507180Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5480601750718854806017507188
3480601750718434806017507184
1480601750718014806017507180

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 Volume5Milliliter

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
718848773
Device count
100
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
08800045103061Feel Ject(FIS-054, U-100, 1.0cc, 31G x 6mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105164Feel Ject(FIS-202, U-100, 0.3 cc, 29G x 12.7mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105256Feel Ject(FIS-205, U-100, 0.3 cc, 31G x 8mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105492Feel Ject(FIS-213, U-100, 1.0cc, 31G x 8mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105614Feel Ject(FIS-217, U-100, 0.5 cc, 31G x 6mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
00810131885045ION Non CervicalSurgentec, LLCFMF2026-07-28
00884450486955Merit Medical®Merit Medical Systems, Inc.FMF2026-07-25
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
05391530753944Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
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