FDA.reportPublic FDA data

PIP

Primary DI
00732671009319
Brand
PIP
Company
AMITY HOLDINGS, LLC
Model
931
Catalog number
931
Device description
Insulin Pen Needle 32ga X 4.0mm
Published
2019-12-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
true
Single use
true

Contact Domains#

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
10732671109313PackageGS1100In Commercial Distribution
20732671209317PackageGS112In Commercial Distribution
30732671309311PackageGS14In Commercial Distribution
40732671409315PackageGS15In Commercial Distribution
50732671509319PackageGS110In Commercial Distribution
60732671609313PackageGS150In Commercial Distribution
00732671009319PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1073267110931310732671109313
2073267120931720732671209317
3073267130931130732671309311
4073267140931540732671409315
5073267150931950732671509319
6073267160931360732671609313
00732671009319007326710093197326710093190732671009319

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Needle Gauge0

Contacts#

Phone, Email table
PhoneEmail
615-545-1503josh@amity-holdings.com

Regulatory Flags#

DUNS number
016069284
Device count
1
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00732671009326PIP9329322019-12-30
00732671009418Pip9419412021-06-21
10732671209426Pip9429422021-06-21
00732671109422Pip 942-2942-22021-06-21
30732671309403Pip940-50940-502026-04-16
00732671009401Pip9409402021-06-21
00732671009425Pip 942-1942-12021-06-21
10732671109023Pip9029022020-08-27
10732671109030PIP9039032020-08-27
10732671105315LiteTouch5312016-09-01
10732671105322LiteTouch5322016-09-01
10732671105339LiteTouch5332016-09-01
10732671105346LiteTouch5342016-09-01
10732671105353LiteTouch5352016-09-01
10732671106176LiteTouch6172016-09-01
10732671106183LiteTouch6182016-09-01
00732671021182LiteTouch211821182021-12-21
00732671022110LiteTouch 221122112021-06-21
00732671022127LiteTouch221222122021-06-21
00732671022134LiteTouch 221322132021-06-21

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