FDA.reportPublic FDA data

safety hypodermic needles

Primary DI
16949236203575
Brand
safety hypodermic needles
Company
Berpu Medical Technology Co.,Ltd
Model
25Gx5/8"(0.5x16mm)
Published
2022-11-21
Public version status
New
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
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16949236203575PackageGS1100In Commercial Distribution
26949236203572PackageGS120In Commercial Distribution
06949236203578PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1694923620357516949236203575
2694923620357226949236203572
06949236203578069492362035786949236203578

GMDN Terms#

Term, Definition table
TermDefinition
Hypodermic needle, single-useA non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). 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

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