FDA.report

NIPRO HYPODERMIC NEEDLE

Primary DI
40383790002149
Brand
NIPRO HYPODERMIC NEEDLE
Company
NIPRO MEDICAL CORPORATION
Model
AH+3013
Catalog number
AH+3013-1M
Published
2016-09-23
Public version status
Update
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
10383790002148PackageGS1100In Commercial Distribution
20383790002145PackageGS110In Commercial Distribution
40383790002149PackageGS110In Commercial Distribution
00383790002141PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1038379000214810383790002148
2038379000214520383790002145
4038379000214940383790002149
00383790002141003837900021413837900021410383790002141

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
Device Size Text, specify0
Needle Gauge30Gauge

Sterilization Methods

Method

Contacts

PhoneEmail
+1 (908) 393-7030info@nipromed.com

Regulatory Flags

DUNS number
797372554
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
false
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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10383790011935NIPRO SYRINGEJD+10L2025-06-01
10383790011942NIPRO SYRINGEJD+10L20252025-06-01
10383790011959NIPRO SYRINGEJD+10L20382025-06-01
10383790011966NIPRO SYRINGEJD+10L21252025-06-01
10383790011973NIPRO SYRINGEJD+10L21382025-06-01
10383790011980NIPRO SYRINGEJD+10L22252025-06-01
10383790011997NIPRO SYRINGEJD+10L22382025-06-01
10383790000304Nipro SafeTouch TULIP Safety Fistula NeedleFT+142530BC2023-09-15
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