AccessGUDID - DEVICE: Angel Blood Access Kits (NA) (10852714003030)

GUDID

Device Identifier (DI) Information

Brand Name: Angel Blood Access Kits (NA)
Version or Model: 976000502
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NUO THERAPEUTICS INC

Primary DI Number: 10852714003030
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 132418851 *Terms of Use

Device Description: Angel Blood Access Kits (NA) Case of 8 Kits or 8 Trays with 966100178 NA BAK Kit Label

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):	No
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?
18026	Phlebotomy kit	A collection of devices and supplies used in the practice of collecting blood samples. It typically consists of test tubes, racks, needles, bandages, gauze pads, and a sharps container. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ORG	Platelet And Plasma Separator For Bone Graft Handling

FDA Premarket Submission

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

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: 51400cef-6bc7-4df7-93d3-8cca59d4d243
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 19, 2016