FDA.reportPublic FDA data

Disposable Insulin Syringe

Primary DI
06949236201710
Brand
Disposable Insulin Syringe
Company
Berpu Medical Technology Co.,Ltd
Model
U-100 0.3ML 31G×8mm Protective end top
Published
2017-03-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
K162180000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162180000Disposable Insulin SyringeBerpu Medical Technology Co., Ltd.2016-12-29FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06949236201192PackageGS1100In Commercial Distribution
06949236201710PackageGS130In Commercial Distribution
06949236200676PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06949236201192069492362011926949236201192
06949236201710069492362017106949236201710
06949236200676069492362006766949236200676

GMDN Terms#

Term, Definition table
TermDefinition
Insulin syringe/needle, safetyA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer an injection of insulin to a patient subcutaneously; it includes an attached needle with a safety mechanism, such as cylinder/flap shielding or retraction into the barrel or sleeve after use, providing protection against needle sticks and rendering the device unusable. The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties (internally precoated with compatible substances) allowing smooth plunger movement. It can be used by healthcare personnel or patients.. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529239746
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
06949236203493safety hypodermic needles"18Gx1""(1.2x25mm)"2022-11-21
06949236203509safety hypodermic needles"18Gx1 1/2""(1.2x38mm)"2022-11-21
06949236203516safety hypodermic needles"20Gx1""(0.9x25mm)"2022-11-21
06949236203523safety hypodermic needles"21Gx1""(0.8x25mm)"2022-11-21
06949236203530safety hypodermic needles"21Gx1 1/2""(0.8x38mm)"2022-11-21
06949236203547safety hypodermic needles"22Gx1""(0.7x25mm)"2022-11-21
06949236203554safety hypodermic needles"22Gx1 1/2""(0.7x38mm)"2022-11-21
06949236203561safety hypodermic needles"23Gx1""(0.6x25mm)"2022-11-21
06949236203578safety hypodermic needles"25Gx5/8""(0.5x16mm)"2022-11-21
06949236203585safety hypodermic needles"25Gx1""(0.5x25mm)"2022-11-21
06949236203592safety hypodermic needles"27Gx1/2""(0.4x13mm)"2022-11-21
06949236203608safety hypodermic needles"30Gx1/2""(0.31x13mm)"2022-11-21
16949236203490safety hypodermic needles18Gx1"(1.2x25mm)2022-11-21
16949236203506safety hypodermic needles18Gx1 1/2"(1.2x38mm)2022-11-21
16949236203513safety hypodermic needles20Gx1"(0.9x25mm)2022-11-21
16949236203520safety hypodermic needles21Gx1"(0.8x25mm)2022-11-21
16949236203537safety hypodermic needles21Gx1 1/2"(0.8x38mm)2022-11-21
16949236203544safety hypodermic needles22Gx1"(0.7x25mm)2022-11-21
16949236203551safety hypodermic needles22Gx1 1/2"(0.7x38mm)2022-11-21
16949236203568safety hypodermic needles23Gx1"(0.6x25mm)2022-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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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