FDA.reportPublic FDA data

AboutTime 32G x 4mm Pen Neddles

Primary DI
00628465145212
Brand
AboutTime 32G x 4mm Pen Neddles
Company
Medical Plastic Devices M.P.D. Inc
Model
1
Device description
AboutTime 32G x 4mm Pen Neddles, Universal fit
Published
2020-02-24
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

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
00628465045215PrimaryGS10
00628465145212Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628465045215006284650452156284650452150628465045215
00628465145212006284651452126284651452120628465145212

GMDN Terms#

Term, Definition table
TermDefinition
Autoinjector needleA device designed for the parenteral administration of a drug contained in a cartridge that forms part of, is attached to, or inserted into an autoinjector (drug pen injector). It is used by persons requiring regular, self-administrated dosages of insulin, hormones, or other pharmaceuticals. This device will typically be constructed as a double-ended, stainless steel needle of various sizes that is fixed to a threaded hub of plastic to which the drug pen injector is connected. This device is packaged in a sealed sterility barrier, and might include needle shielding safety features to reduce the risk of needle stick injury. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
244897773
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628465003314MPD LancetThin 23GaP03312020-09-30
00628465003512MPD LancetThin 23GaP03512020-09-30
00628465005318MPD LancetThin 23GaP03312020-09-30
00628465105513MPD LancetThin 23GaP03512020-09-30
00628465003628MPD LancetUltra Thin 26GaP03622020-09-26
00628465103625MPD LancetUltra Thin 26GaP03622020-09-26
00628465003611MPD Lancet Ultra Thin (Box of 100)1P03612020-02-21
00628465103618MPD Lancet Ultra Thin (Box of 100)1P03612020-02-21
00628465014525AboutTime MPD 21Gx 1.8mm Safety Lancet1P14522020-02-25
00628465014556AboutTime MPD 23G x1.8mm Safety Lancet1P14552020-02-25
00628465014563AboutTime MPD 28G x 1.8mm Safety Lancet1P14562020-02-25
00628465014587AboutTime MPD 30Gx1.8mm Safety Lancet1P14582020-02-25
00628465114522AboutTime MPD 21Gx 1.8mm Safety Lancet1P14522020-02-25
00628465114553AboutTime MPD 23G x1.8mm Safety Lancet1P14552020-02-25
00628465114560AboutTime MPD 28G x 1.8mm Safety Lancet1P14562020-02-25
00628465114584AboutTime MPD 30Gx1.8mm Safety Lancet1P14582020-02-25
00628465045215AboutTime 32G x 4mm Pen Neddles12020-02-24
00628465045284AboutTime 30G x 8mm Pen Neddles12020-02-24
00628465045253AboutTime 31G x 5mm Pen Needles1P45252020-02-24
00628465145281AboutTime 30G x 8mm Pen Neddles12020-02-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M6898250403050MEDIC ENHANCEMENT SETSafeguard US Operating, LLCFMI2026-06-03
08056999020279SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020286SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020293SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020309SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020316SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020323SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020330SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020347SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020354SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020361SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020385SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
08056999020408SurTract™RONCADELLE OPERATIONS SRLFMI2026-05-31
00840464800019Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800026Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800033Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800040Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800057Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800064Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
10840330704868ProCureTwin Med, LLCFMI2026-05-27
10840330704875ProCureTwin Med, LLCFMI2026-05-27
08586015044786CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044793CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044809CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044816CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044823CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044830CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044847CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044854CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044861CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27