AccessGUDID - DEVICE: PRIMO (00840216113183)

GUDID

Device Identifier (DI) Information

Brand Name: PRIMO
Version or Model: GGTS05
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Asp Global, LLC

Primary DI Number: 00840216113183
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080361159 *Terms of Use

Device Description: G&G BARIATRIC ANGLED BUNDLE; 1 EACH - 36" X 60" TURN SHEET & 2 EACH - 15" LONG ROUNDED WEDGES

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
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?
37165	Patient transfer/turning sheet, single-use	A manual device in the form of a non-inflatable sheet or mat intended to be used by healthcare professionals to assist in the physical movement and/or transfer of a recumbent patient from one position/location to another. The device may operate using sliding/rolling and/or lifting techniques to move the patient upon it. It is typically made of plastics or textiles and may incorporate handles. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMP	Protector, Skin Pressure

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: 405dec9a-baa7-4cd9-a580-f07c3034bc98
Public Version Date: October 21, 2024
Public Version Number: 4
DI Record Publish Date: March 18, 2022