AccessGUDID - DEVICE: Bosma Enterprises (00818634020833)

GUDID

Device Identifier (DI) Information

Brand Name: Bosma Enterprises
Version or Model: 10-9030PTD
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10-9030PTD
Company Name: Bosma Enterprises

Primary DI Number: 00818634020833
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 878070325 *Terms of Use

Device Description: Patient Transportation PTD Kit; Each Kit Includes STAT-BLOC Disposable Antimicrobial Impervious Standard Table Sheet, and 20x15 Large White Dry Wipe.

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?
45171	Dry medical towel/wipe, single-use	A dry fabric intended to be used to wipe or dry a patient’s intact skin (not related to wound care), clean medical devices/equipment (e.g., endoscopes, ultrasound systems), and/or clean the general environment (e.g., fluid spill). It may be moistened (e.g., with water or used together with disinfectant/cleaning solutions) however no solutions are included. Some devices may be provided sterile, or designed to be sterilized, for use under sterile conditions [e.g., within an operating room (OR)]; devices intended for non-surgical applications may be provided and used in a non-sterile state. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PWU	Clean-Up Kit

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
Special Storage Condition, Specify: Avoid excessive heat. Keep dry.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 29de1ad3-1878-4c94-8cf8-dbf917fdd5bf
Public Version Date: July 12, 2021
Public Version Number: 1
DI Record Publish Date: July 02, 2021