BD Hypoint™

Primary DI
50382903002554
Brand
BD Hypoint™
Company
BECTON DICKINSON MEDICAL (S) PTE LTD
Model
300255
Catalog number
300255
Device description
BD Hypoint Needle is a hypodermic single lumen needle designed, for use with syringes and injection devices for general purpose fluid injection /aspiration.
Published
2020-04-24
Public version status
New
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
FMINeedle, hypodermic, single lumen

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070440000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070440000BD HYPOINT NEEDLEBecton, Dickinson & CO2007-03-16FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50382903002554PackageGS15000In Commercial Distribution
00382903002559PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5038290300255450382903002554
00382903002559003829030025593829030025590382903002559

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0.5Inch
Needle Gauge27Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
595883083
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
00382903002085BD Hypoint™3002083002082020-04-24
00382903002559BD Hypoint™3002553002552020-04-24
00382903002498BD Hypoint™3002493002492020-04-24
00382903002535BD Hypoint™3002533002532021-01-21
00382903002634BD Hypoint™3002633002632020-04-24
00382903002641BD Hypoint™3002643002642020-04-24
00382903013906BD Hypoint™3013903013902020-04-24
50382903002530BD Hypoint™3002533002532021-01-21
50382903002080BD Hypoint™3002083002082020-04-24
50382903002493BD Hypoint™3002493002492020-04-24
50382903002639BD Hypoint™3002633002632020-04-24
50382903002646BD Hypoint™3002643002642020-04-24
50382903013901BD Hypoint™3013903013902020-04-24

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