FDA.report

Endure

Primary DI
00840118603232
Brand
Endure
Company
ENDURE INDUSTRIES
Model
NH2315A4-0520
Catalog number
NH2315A4
Device description
Hypodermic Needles, 23G, 1 1/2", Sterile
Published
2020-09-29
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

Related Records

Contact Domains

Product Codes

CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications

CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840118603232PackageGS1100In Commercial Distribution
00840118603249PackageGS140In Commercial Distribution
00840118603225PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840118603232008401186032328401186032320840118603232
00840118603249008401186032498401186032490840118603249
00840118603225008401186032258401186032250840118603225

GMDN Terms

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

TypeValueUnit
Catheter Length1.5Inch
Needle Gauge23Gauge

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius49 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
6072994971Support@endureind.com

Regulatory Flags

DUNS number
066087031
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
true
Sterilization required before use
false

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00840118608077ENDURE INDUSTRIESNROMP11NROMP112024-04-10
00840118615297ENDURE INDUSTRIESGS13GS132024-04-10
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00840118611619ENDURE INDUSTRIESNROMPE11NROMPE112024-04-10

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