FDA.reportPublic FDA data

NIPRO HYPODERMIC NEEDLE

Primary DI
40383790001852
Brand
NIPRO HYPODERMIC NEEDLE
Company
NIPRO MEDICAL CORPORATION
Model
AH+1838
Catalog number
AH+1838-1M
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10383790001851PackageGS1100In Commercial Distribution
20383790001858PackageGS110In Commercial Distribution
40383790001852PackageGS110In Commercial Distribution
00383790001854PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038379000185110383790001851
2038379000185820383790001858
4038379000185240383790001852
00383790001854003837900018543837900018540383790001854

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
Device Size Text, specify0
Needle Gauge18Gauge

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
40383790012377Blood pressure cuff for SURDIAL DX Hemodialysis SystemHXA-GCUFF-SRA2025-12-19
40383790012384Blood pressure cuff for SURDIAL DX Hemodialysis SystemHXA-GCUFF-MRA2025-12-19
40383790012391Blood pressure cuff for SURDIAL DX Hemodialysis SystemHXA-GCUFF-LRA2025-12-19
40383790012407Blood pressure cuff for SURDIAL DX Hemodialysis SystemHXA-GCUFF-XLRA2025-12-19
40383790012414Blood pressure cuff hose for SURDIAL DX Hemodialysis SystemHXA-CUFFH-GR35R2025-12-19
40383790011875SLIMLINE™ BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SETBL+A226Y/V813-NIJ2025-06-01
40383790011882NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SETBL+A217Y/V806-NIJ2025-06-01
40383790011899NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SETBL+A209Y/V803-NIJ2025-06-01
40383790011905NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SETBL+A223D/V809D-NIJ2025-06-01
40383790011912Nipro Set Blood Tubing SetBL+A430/V912-NIJ2025-06-01
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
00383790000345Nipro SafeTouch TULIP Safety Fistula NeedleFT+142530TP2023-09-15
10383790000366Nipro SafeTouch TULIP Safety Fistula NeedleFT+152530BC2023-09-15

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Primary DI, Brand, Company table
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