BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

H.E.B. inControl

DI: 00041220916504 · Model: AT 0575HEB · H. E. BUTT GROCERY COMPANY

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Product Codes

1

GMDN Terms

1

Identifiers

3

Pkg Device Count

100

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Basic Information

Brand Name: H.E.B. inControl
Primary DI: 00041220916504
Version / Model: AT 0575HEB
Company Name: H. E. BUTT GROCERY COMPANY
Labeler DUNS: 007924756
Distribution Status: In Commercial Distribution
Device Count in Pkg: 100
Record Status: Published
Publish Date: 2023-01-09
Public Version: 1
Public Version Date: 2023-01-17
Public Version Status: New
Public Device Record Key: d570666f-152b-4763-986f-dfa0a403fe6e

Device Description

H.E.B. inControl Super Thin Lancets 30g 100 count

Device Characteristics

Single Use: Yes
Prescription Use (Rx): No
Over the Counter (OTC): Yes
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: Yes
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: No
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: Yes
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QRK	Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	878.4850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45142	Blood lancing device tip	A sterile, sharp, needle-like device intended to be loaded into a blood lancing device to function as the invasive portion of the assembly during skin puncture for capillary blood sampling, typically performed at a fingertip or ear lobe (e.g., by diabetic patients). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00761059577270	GS1	Case	200	In Commercial Distribution
Primary	00041220916504	GS1
Unit of Use	00384700575007	GS1

Device Sizes

Type	Value	Unit	Text
Needle Gauge	30	Gauge