FDA.reportPublic FDA data

HEPRO.US Syringes with Attached Needle 5ml/cc 20G x 1”

Primary DI
00854427007643
Brand
HEPRO.US Syringes with Attached Needle 5ml/cc 20G x 1”
Company
HEPRO.US INC.
Model
BX 5ml/cc 20G x 1”
Device description
HEPRO.US Syringes with Attached Needle 5ml/cc 20G x 1” – 100pcs – 1 Box
Published
2017-06-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854427007643PrimaryGS10
85442700764301Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854427007643008544270076438544270076430854427007643
8544270076430185442700764301

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe, single-useA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080061451
Device count
100
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854427007056HEPRO.US Standard Surgical Gown CaseCT - Standard Surgical Gown Spunlace2017-06-21
00854427007063HEPRO.US Reinforced Surgical Gown Case 43gsmCT - Reinforced Surgical Gown 43gsm SMMS2017-06-21
00854427007841HEPRO.US Standard Surgical Gown L 43gsm 1 PouchSingle Pouch Standard Surgical gown SMMS2017-06-20
00854427007858HEPRO.US Reinforced Surgical Gown L 43gsm Single Pouch Reinforced Surgical Gown 43gsm SMMS2017-06-20
00854427007964HEPRO.US Standard Surgical Gown 68 gsmSingle Pouch Standard Surgical Gown 68gsm2017-06-20
00854427007971HEPRO.US Reinforced Surgical Gown Single Pouch 68gsmSingle Pouch Reinforced Surgical Gown 68gsm2017-06-20
00850578007174HEPRO.US Disposable Nitrile Gloves Class 450 SmallBX - 450 Nitrile Small 2017-06-21
00850578007181HEPRO.US - Disposable Nitrile Gloves Class 400 SmallCT - 400 Nitrile Small 2017-06-21
00850578007655HEPRO.US Latex Examination Gloves Size MediumCT - Latex Exam Medium 2017-06-21
00850578007662HEPRO.US Case of 10 boxes LARGE Latex Examination GlovesCT - Latex Exam Large2017-06-21
00850578007730HEPRO.US - Latex Examination Gloves SMALL - 100 in one BoxBX Latex Exam Small2017-06-21
00850578007754HEPRO.US – Latex Examination Gloves – 100 per Box - Size MediumBX - Latex Exam Medium 2017-06-21
00850578007761HEPRO.US Latex Examination Gloves Size Large BX - Latex Exam Large 2017-06-21
00850578007785"HEPRO.US Sterile Latex Surgical Gloves 7""""BX Surgical Latex Gloves 7"""2017-06-21
00850578007792"HEPRO.US Sterile Latex Surgical Gloves 7.5""""BX Surgical Latex Gloves 7.5"""2017-06-21
00850578007822HEPRO.US Nitrile Standard Class Series 350BX - 350 Nitrile Small 2017-06-21
00850578007839HEPRO.US Nitrile Standard Class Medium Series 350 BX - 350 Nitrile Medium 2017-06-21
00850578007846HEPRO.US - Nitrile Disposable Gloves Deluxe Class 350 Non-Powdered TexturedBX - 350 Nitrile Large 2017-06-21
00850578007853HEPRO.US Nitrile Standard Class Series 350 - 1 Box 100pcsBX - 350 Nitrile XL2017-06-21
00850578007860HEPRO.US Nitrile Standard Class Series 400BX - 400 Nitrile Small 2017-06-21

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