BD MiniDraw Finger Sizing Tool 366617-100

GUDID 00382903666171

BD MiniDraw Finger Sizing Tool

Babson Diagnostics, Inc.

Capillary blood collection finger diameter sizer IVD
Primary Device ID00382903666171
NIH Device Record Keye2fbd7d1-77f3-465b-b33f-fb6c41fb58d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameBD MiniDraw Finger Sizing Tool
Version Model Number366617-100
Catalog Number366617-100
Company DUNS059454260
Company NameBabson Diagnostics, Inc.
Device Count100
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100382903666171 [Unit of Use]
GS100850058457055 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GIMTubes, Vacuum Sample, With Anticoagulant

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-17
Device Publish Date2025-12-09

Devices Manufactured by Babson Diagnostics, Inc.

00850058457031 - BD MiniDraw Capillary Tube Adapter SST2025-12-17 BD MiniDraw Capillary Tube Adapter SST
00382903666171 - BD MiniDraw Finger Sizing Tool2025-12-17BD MiniDraw Finger Sizing Tool
00382903666171 - BD MiniDraw Finger Sizing Tool2025-12-17 BD MiniDraw Finger Sizing Tool
00850058457017 - Babson Sample Preparation Device2024-05-21 The Babson Sample Preparation Device is a class I exempt device that falls within 21 CFR 862.2050, General purpose laboratory eq
00850058457000 - Babson Hand Warmer2024-01-22 The Babson Hand Warmer is a powered heating device that provides heat to the palm of the hand to aid in blood collection. It is

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