FDA.reportPublic FDA data

PurCel Labs Safety Insulin Pen Needles (31G x 5mm)

Primary DI
00810143550429
Brand
PurCel Labs Safety Insulin Pen Needles (31G x 5mm)
Company
Purcel Labs LLC
Model
1087-100
Device description
Insulin Safety Pen Needle, Sterile, Single Use, 31G x 5mm, (100/Box).
Published
2023-08-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213183000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213183000Safety Insulin Pen NeedlesZhejiang Kindly Medical Devices Co., Ltd.2022-10-14FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810143550481PackageGS110In Commercial Distribution
00810143550498PackageGS16In Commercial Distribution
00810143550429PrimaryGS10
10810143550426Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810143550481008101435504818101435504810810143550481
00810143550498008101435504988101435504980810143550498
00810143550429008101435504298101435504290810143550429
1081014355042610810143550426

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.

Regulatory Flags#

DUNS number
127672531
Device count
100
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810143550221PurCel Labs Small Vinyl Exam Gloves1200-1502023-08-04
00810143550252PurCel Labs Medium Vinyl Exam Gloves1201-1502023-08-04
00810143550283PurCel Labs Large Vinyl Exam Gloves1202-1502023-08-04
00810143550313PurCel Labs XL Vinyl Exam Gloves1203-1502023-08-04
00810143550573PurCel Labs Small 4 MIL Black Exam Gloves1400-1002023-08-15
00810143550603PurCel Labs Medium 4 MIL Black Exam Gloves1401-1002023-08-15
00810143550634PurCel Labs Large 4 MIL Black Exam Gloves1402-1002023-08-15
00810143550665PurCel Labs XL 4 MIL Black Exam Gloves1403-1002023-08-15
00810143550771PurCel Labs ASTM Level 1 Surgical Masks3000-502023-08-18
00810143550795PurCel Labs Individually Wrapped ASTM Level 1 Surgical Masks3001-502023-08-18
00810143550405 PurCel Labs Safety Insulin Pen Needles (32G x 4mm)1086-1002023-08-08
00810143550443PurCel Labs Safety Insulin Pen Needles (30G x 6mm)1088-1002023-08-08
10810143550402 PurCel Labs Safety Insulin Pen Needles (32G x 4mm)1086-1002023-08-08
00810143550481 PurCel Labs Safety Insulin Pen Needles (31G x 5mm)1087-1002023-08-08
00810143550504PurCel Labs Safety Insulin Pen Needles (30G x 6mm)1088-1002023-08-08
00810143550788PurCel Labs ASTM Level 1 Surgical Masks3000-502023-08-18
00810143550801PurCel Labs Individually Wrapped ASTM Level 1 Surgical Masks3001-502023-08-18
00810143550580PurCel Labs Small 4 MIL Black Exam Gloves1400-1002023-08-15
00810143550610PurCel Labs Medium 4 MIL Black Exam Gloves1401-1002023-08-15
00810143550641PurCel Labs Large 4 MIL Black Exam Gloves1402-1002023-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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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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00840464800033Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800040Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800057Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
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10840330704868ProCureTwin Med, LLCFMI2026-05-27
10840330704875ProCureTwin Med, LLCFMI2026-05-27
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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