AccessGUDID - DEVICE: A Plus (00683534080436)

GUDID

Device Identifier (DI) Information

Brand Name: A Plus
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BT44044-1
Company Name: A PLUS INTERNATIONAL INC.

Primary DI Number: 00683534080436
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 191705904 *Terms of Use

Device Description: BackTablCovr44x44 2200/G;2.25mil,N-S,fan

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":	Yes
For Single-Use:	Yes
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?
60823	Bed linen set	A collection of bedding materials including a bed sheet, pillow cover, and a duvet cover all typically made of a thin non-woven or textile laminate intended to create a physical barrier to soiling and cross-contamination. It does not include antimicrobial properties. This set 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
FWZ	Operating Room Accessories Table Tray

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: Yes

Sterilization Method [?]
Ethylene Oxide

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: e04de885-9119-4a3e-bc6a-6cc97e24bc90
Public Version Date: June 19, 2024
Public Version Number: 2
DI Record Publish Date: November 17, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
80683534080432	2200	00683534080436		In Commercial Distribution	Case

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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