AccessGUDID - DEVICE: RedDrop Dx (00860011954002)

GUDID

Device Identifier (DI) Information

Brand Name: RedDrop Dx
Version or Model: 300-25-007
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: REDDROP DX, INC.

Primary DI Number: 00860011954002
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 111267004 *Terms of Use

Device Description: The RedDrop One is a single-use blood lancing device intended for producing microliter capillary whole blood samples. It does not collect or transport such samples.

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 [?]
K234081	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0ec3a726-7913-4c72-b4f2-b90732b73b2e
Public Version Date: July 31, 2024
Public Version Number: 1
DI Record Publish Date: July 23, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status
00860011954033	50	00860011954002	In Commercial Distribution
00860011954026	84	00860011954002	In Commercial Distribution
00860011954019	10	00860011954002	In Commercial Distribution