FDA.reportPublic FDA data

Embrace Pen Needle 31G @5mm

Primary DI
00894030002116
Brand
Embrace Pen Needle 31G @5mm
Company
OMNIS HEALTH, LLC
Model
SHN02MM31.05
Catalog number
SHN02MM31.05
Device description
Insulin pen needle 31G 5mm 100 ct.
Published
2022-11-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193422000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193422000Easydrip Pen Needle, Easydrip Plus Pen NeedleSandstone Medical (Suzhou), Inc.2021-02-02FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00894030002116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00894030002116008940300021168940300021160894030002116

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
824763358
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00894030002031Embrace Pen Needle 30G @8mmSHN02MM30.08SHN02MM30.082022-11-29
00894030002055Embrace Pen Needle 31G @6mmSHN02MM31.06SHN02MM31.062022-11-29
00894030002109 Embrace Pen Needle 29G @12mmSHN02MM29.12SHN02MM29.122022-11-29
00894030002123Embrace Pen Needle 31G @8mmSHN02MM31.08SHN02MM31.082022-11-29
00894030002130Embrace Pen Needle 32G @4mmSHN02MM32.04SHN02MM32.042022-11-29
00894030002529Embrace Pen Needle 30G @5mmSHN02MM30.05SHN02MM30.052022-11-29
00894030002277EmbraceWAVE+ Pre-Pack (3x24)APX04AB0400BTPRAPX04AB0400BTPR2023-03-23
00894030002178EmbraceWAVE+ Blood Glucose MeterAPX04AB0400BT2023-01-11
00894030002185EmbraceWAVE+ Blood Glucose Monitoring System Starter KitAPX04AB0401BT2023-01-11
00894030002192EmbraceWAVE+ Blood Glucose Monitoring System Value PackAPX04AB0402BT2023-01-11
00894030002208EmbraceWAVE Blood Glucose Test Strips 25 ct.APX04AB04032023-01-11
00894030002215EmbraceWAVE Blood Glucose Test Strips 50 ct.APX04AB04042023-01-11
00894030002222EmbraceWAVE Blood Glucose Test Strips 100 ct.APX04AB04052023-01-11
00894030002239EmbraceWAVE Glucose Control Solution Low (L1)APX04AB04062023-01-11
00894030002246EmbraceWAVE Glucose Control Solution High (L2)APX04AB04072023-01-11
00894030002093Embrace TALK Blood Glucose Monitor (Pre-Pack 3 x 15)APX03AB0301PREAPX03AB0301PRE2022-11-01
00894030002598HealthWise Embrace TALK Pre-Pack (3x15)APX03AB0313HWPRAPX03AB0313HWPR2022-10-27
00894030002048Embrace LancetSHN02GM01232021-07-01
00894030002611Embrace Blood Glucose MonitorAPX01AB0200N2021-09-23
00894030002512Embrace Safety LancetSHN02GX21.222021-07-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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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
08586015044878CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27