AccessGUDID - DEVICE: Curaplex (00812277038224)

GUDID

Device Identifier (DI) Information

Brand Name: Curaplex
Version or Model: 301-PASC107
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 301-PASC107
Company Name: BOUND TREE MEDICAL, LLC

Primary DI Number: 00812277038224
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070556204 *Terms of Use

Device Description: O2 DELIVERY KIT, PACU 50/CA

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):	Yes
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?
12855	Oxygen administration kit, sterile	A collection of sterile devices designed for oxygen (O2) delivery that may include a mask, a nasal cannula, oxygen tubing, and connectors. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
BYG	MASK, OXYGEN

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: 10156d40-d6bd-40b1-b9f7-0dd92b949be7
Public Version Date: January 09, 2023
Public Version Number: 1
DI Record Publish Date: December 30, 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
00810071630361	3	00812277039481		In Commercial Distribution	CS
00812277039481	20	00812277038224		In Commercial Distribution	BX

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: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

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

Customer Contact

[?]

No Customer Contact currently defined

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