AccessGUDID - DEVICE: Bosma Enterprises (00818634020307)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 00818634020307
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 878070325 *Terms of Use

Device Description: Patient Transportation PTT Kit; Each Kit Includes STAT-BLOC Disposable Premium Antimicrobial Impervious Partially-Fitted Gurney Sheet, 34x66 Disposable Standard Draw Sheet, and STAT-BLOC Disposable Pillowcase.

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?
37456	Pillow cover, single-use	A device made of an impermeable material that fits over a pillow, and under a pillowcase, to reduce allergen levels or for infection control. This is a single-use device.	Active	false
47456	Basic bed sheet, single-use	A large piece of fabric material intended to cover the mattress of a bed to protect it from being soiled and to provide the bed's occupant with clean, non-irritating contact surfaces (over and under); it does not include antimicrobial or nonadherent properties. It is typically made of a thin-textile or reinforced-paper material. This device is intended to be used by one patient for a limited time, without laundering, and then discarded (e.g., incinerated).	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: c51f607a-25bb-4923-9c0a-7dbd5315e8d6
Public Version Date: July 12, 2021
Public Version Number: 1
DI Record Publish Date: July 02, 2021