AccessGUDID - DEVICE: BD Microtainer® Quikheel™ Preemie Lancet (30382903681007)

GUDID

Device Identifier (DI) Information

Brand Name: BD Microtainer® Quikheel™ Preemie Lancet
Version or Model: 368100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 368100
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 30382903681007
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 001292192 *Terms of Use

Device Description: LANCET QUIKHEEL PINK 0.85MMX1.75MM

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61578	Manual blood lancing device, single-use	A sterile, hand-held manual instrument intended to be used for controlled skin puncture/cut to obtain a capillary blood specimen, performed by a healthcare provider (e.g., on a neonate) or a patient (e.g., a diabetic), typically at the fingertip or ear lobe. It includes a preloaded lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMK	Single use only blood lancet with an integral sharps injury prevention feature

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K223243	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Room Temperature

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e0f094bf-b854-4ebb-aa52-8fd49b2cb9ea
Public Version Date: February 27, 2024
Public Version Number: 2
DI Record Publish Date: March 15, 2023