FDA.report

MEDLINE

Primary DI
40888277358462
Company
MEDLINE INDUSTRIES, INC.
Model
MPHPN318
Catalog number
MPHPN318
Device description
PEN NEEDLE, 31G X 8MM
Published
2026-03-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Related Records

Regulatory Flags

DUNS number
025460908
Device count
100
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

Identifiers

IdentifierTypeAgencyPackage quantityStatus
40888277358462PackageGS110In Commercial Distribution
00888277358464PrimaryGS10
10888277358461Unit of UseGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
40888277358462PackageGS110CS00888277358464In Commercial Distribution
00888277358464PrimaryGS10
10888277358461Unit of UseGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
FMINeedle, Hypodermic, Single Lumen2General Hospital880.5570NIneligible

Premarket Submissions

No records found.

Premarket Details

No records found.

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

TypeValueText
Device Size Text, specify031G, 8mm

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

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