BD Hypoint™

Primary DI
00382903002498
Brand
BD Hypoint™
Company
BECTON DICKINSON MEDICAL (S) PTE LTD
Model
300249
Catalog number
300249
Device description
HYPOINT Needle 23 Guage 1 inch TW; sterile single use needle
Published
2020-04-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
50382903002493PackageGS15000Not in Commercial Distribution
00382903002498PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5038290300249350382903002493
00382903002498003829030024983829030024980382903002498

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
Length1Inch
Needle Gauge23Gauge

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
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382903002085BD Hypoint™3002083002082020-04-24
00382903002559BD Hypoint™3002553002552020-04-24
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
50382903002554BD Hypoint™3002553002552020-04-24
50382903002639BD Hypoint™3002633002632020-04-24
50382903002646BD Hypoint™3002643002642020-04-24
50382903013901BD Hypoint™3013903013902020-04-24

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