FDA.reportPublic FDA data

PIP

Primary DI
10732671109030
Brand
PIP
Company
AMITY HOLDINGS, LLC DBA PIP DIABETES CARE
Model
903
Catalog number
903
Device description
Safety Lancet
Published
2020-08-27
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMKLancet, Blood

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention FeatureGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00732671009036PackageGS1100In Commercial Distribution
20732671209034PackageGS110Not in Commercial Distribution
20732671209133PackageGS14In Commercial Distribution
30732671309038PackageGS14Not in Commercial Distribution
40732671409032PackageGS110In Commercial Distribution
50732671509036PackageGS130In Commercial Distribution
10732671109030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00732671009036007326710090367326710090360732671009036
2073267120903420732671209034
2073267120913320732671209133
3073267130903830732671309038
4073267140903240732671409032
5073267150903650732671509036
1073267110903010732671109030

GMDN Terms#

Term, Definition table
TermDefinition
Blood lancet, single-useA sterile, hand-held, sharply-pointed, non-mechanical, scalpel-like instrument intended to be used by a healthcare provider to manually puncture the skin of a patient to obtain a small blood specimen or drain a cyst or boil. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Needle Gauge0

Contacts#

Phone, Email table
PhoneEmail
6155451503josh@amity-holdings.com

Regulatory Flags#

DUNS number
016069284
Device count
1
DM exempt
false
Premarket exempt
true
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
00732671009203PipSK900SK9002026-09-24
10732671100419NovaPlus10041100412020-08-28
10732671100518NovaPlus10051100512020-08-28
10732671105315LiteTouch5312016-09-01
10732671105322LiteTouch5322016-09-01
10732671105339LiteTouch5332016-09-01
10732671105346LiteTouch5342016-09-01
10732671105353LiteTouch5352016-09-01
10732671106176LiteTouch6172016-09-01
10732671106183LiteTouch6182016-09-01
10732671108040ReadyLance8048042020-08-27
10732671108095ReadyLance8098092020-08-27
10732671108163ReadyLance8168162020-08-27
10732671109016PIP9019012020-08-27
10732671109023Pip9029022020-08-27
10732671110036MediHeel100310032020-08-28
10732671110067MediHeel100610062020-08-28
10732671120042MediHeel200420042020-06-01
10732671120059MediHeel200520052020-06-01
10732671180213NovaPlus802180212020-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344235391MEDLINEMEDLINE INDUSTRIES, INC.FMK2026-10-13
00732671009203PipAMITY HOLDINGS, LLC DBA PIP DIABETES CAREFMK2026-09-24
00199536930438BluelineTransparent Supply Solutions Ltd.FMK2026-08-14
00199536930445BluelineTransparent Supply Solutions Ltd.FMK2026-08-14
00199536930452BluelineTransparent Supply Solutions Ltd.FMK2026-08-14
00199536930469BluelineTransparent Supply Solutions Ltd.FMK2026-08-14
00199536930476BluelineTransparent Supply Solutions Ltd.FMK2026-08-14
00199536930483BluelineTransparent Supply Solutions Ltd.FMK2026-08-14
M99260222818UPC3MedtLiteCarelife (usa) Inc.FMK2026-08-07
M99260223016UPC3MedtLiteCarelife (usa) Inc.FMK2026-08-07
00810011730748HuahongTianjin Huahong Technology Co., Ltd.FMK2026-07-10
00810011730762LinkSunTianjin Huahong Technology Co., Ltd.FMK2026-07-10
00810178887750Vive PrecisionVIVE HEALTH LLCFMK2026-06-26
00810178887767Vive PrecisionVIVE HEALTH LLCFMK2026-06-26
00816042013638FORAFORA CARE INC.FMK2026-06-23
00199536930407BluelineTransparent Supply Solutions Ltd.FMK2026-06-05
00199536930414BluelineTransparent Supply Solutions Ltd.FMK2026-06-05
00199536930421BluelineTransparent Supply Solutions Ltd.FMK2026-06-05
00050428359112CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDFMK2026-06-04
00382830006705NeatNickFACET TECHNOLOGIES, LLCFMK2026-06-01
00382830006712NeatNickFACET TECHNOLOGIES, LLCFMK2026-06-01
00840117346505PA Safety Lancets, Pressure Activated, 21 G NeedleDynarex CorporationFMK2026-06-01
08887629010007SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
08887629010106SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
08887629010205SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
08887629010304SAFETIHEELNSP TECH PTE LTDFMK2026-05-29
10840330705605ProCureTwin Med, LLCFMK2026-04-22
10840330705612ProCureTwin Med, LLCFMK2026-04-22
10840330705629ProCureTwin Med, LLCFMK2026-04-22
10840330705636ProCureTwin Med, LLCFMK2026-04-22