PIP 935

GUDID 10732671109351

Lancing Device with Ejector

AMITY HOLDINGS, LLC

Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable
Primary Device ID10732671109351
NIH Device Record Key41ee9600-fb7d-492a-b321-f9a8b98a1131
Commercial Distribution Discontinuation2025-12-30
Commercial Distribution StatusIn Commercial Distribution
Brand NamePIP
Version Model Number935
Catalog Number935
Company DUNS016069284
Company NameAMITY HOLDINGS, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone800 327 8894
Emailwconety@medicore.com
Phone800 327 8894
Emailwconety@medicore.com
Phone800 327 8894
Emailwconety@medicore.com
Phone800 327 8894
Emailwconety@medicore.com
Phone800 327 8894
Emailwconety@medicore.com
Phone800 327 8894
Emailwconety@medicore.com
Phone800 327 8894
Emailwconety@medicore.com
Phone800 327 8894
Emailwconety@medicore.com
Phone800 327 8894
Emailwconety@medicore.com
Phone800 327 8894
Emailwconety@medicore.com
Phone800 327 8894
Emailwconety@medicore.com
Phone800 327 8894
Emailwconety@medicore.com
Phone800 327 8894
Emailwconety@medicore.com
Phone800 327 8894
Emailwconety@medicore.com
Phone800 327 8894
Emailwconety@medicore.com
Phone800 327 8894
Emailwconety@medicore.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100732671009357 [Primary]
GS110732671109351 [Package]
Contains: 00732671009357
Package: Chipboard Box [1 Units]
Discontinued: 2025-12-30
In Commercial Distribution
GS120732671209355 [Package]
Package: Corrugate Carton [100 Units]
Discontinued: 2025-12-30
In Commercial Distribution
GS130732671309359 [Package]
Contains: 20732671209355
Package: Corrugate Carton [400 Units]
Discontinued: 2025-12-30
In Commercial Distribution

FDA Product Code

FMKLancet, Blood

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-07
Device Publish Date2019-12-30

On-Brand Devices [PIP]

10732671109351Lancing Device with Ejector
2073267120934833ga Twist Lancets
30732671309335Insulin Pen Needle 31ga X 6.0mm
30732671309328Insulin Pen Needle 31ga X 5.0mm
30732671309311Insulin Pen Needle 32ga X 4.0mm
00732671009036Safety Lancet
00732671009029Safety Lancet
00732671009012Safety Lancet
60732671609030PIP Trial Pack: 30ea 903; 10ea 901; 10ea 902
60732671609023PIP Trial Pack: 30ea 902; 10ea 901; 10ea 903
60732671609016PIP Lancet Trial Pack: 30ea 901; 10ea 902; 10ea 903
10732671209426Glucose Control Solutions L1(Low) and L2 (High) - 2 Vials 2.5dL each
00732671109422Control Solution - L2 (High)
00732671009425Control Solution - L1 (low)
00732671009418Blood Glucose Test Strips
00732671009401Blood Glucose Test Meter
1073267110233828G Lancet

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