FDA.reportPublic FDA data

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

Primary DI
00810143550481
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
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

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
127672531
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
true
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
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
00810143550429 PurCel Labs Safety Insulin Pen Needles (31G x 5mm)1087-1002023-08-08
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
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

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