AccessGUDID - DEVICE: HEMODROP BLOOD DISPENSER (00853778007128)

GUDID

Device Identifier (DI) Information

Brand Name: HEMODROP BLOOD DISPENSER
Version or Model: BMP-HEMODROP
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Biomedical Polymers, Inc.

Primary DI Number: 00853778007128
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 037687837 *Terms of Use

Device Description: No description.

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
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?
62550	Blood smearing manual instrument IVD	A manual laboratory instrument intended to be used to create a blood smear on a microscope examination slide for subsequent staining and/or microscopic analysis. The device operates with technician involvement in most procedural steps.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

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: 28f900b4-cd1e-4d1a-a2e8-10b975f63067
Public Version Date: August 30, 2023
Public Version Number: 1
DI Record Publish Date: August 22, 2023