AccessGUDID - DEVICE: BIO-PRF (00841336112131)

GUDID

Device Identifier (DI) Information

Brand Name: BIO-PRF
Version or Model: BIO-PRF-BUTTERFLY-COLL-KIT
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SALVIN DENTAL SPECIALTIES, LLC

Primary DI Number: 00841336112131
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 113344790 *Terms of Use

Device Description: BIO-PRF Blood Collection Butterfly Needles with Holders

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:	Yes
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?
65416	Basic intravenous administration set, invasive	A collection of devices which includes a hypodermic needle (e.g., venous butterfly/scalp vein needle) intended to conduct fluids from an intravenous (IV) fluid container to a patient's venous system during administration; it may also be used for blood collection. In addition to the needle, the set may include tubing, connectors, chambers, clamps, gauze pads, alcohol pads and dressings; a bag/bottle may also be included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMI	Needle, Hypodermic, Single Lumen

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K011786	000

Device Exempt from Premarket Submission: No 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: 5683b619-6233-4ede-a2bd-deb008f6d516
Public Version Date: March 06, 2025
Public Version Number: 1
DI Record Publish Date: February 26, 2025