AccessGUDID - DEVICE: Curaplex (00812574025064)

GUDID

Device Identifier (DI) Information

Brand Name: Curaplex
Version or Model: 301-005-10010
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TRI-ANIM HEALTH SERVICES, INC.

Primary DI Number: 00812574025064
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 010712461 *Terms of Use

Device Description: HANDLE,SUCTION,YANKAUER,STRAIGHT TIP,W/O CONTROL VENT,STERILE 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):	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?
10817	Pleural drainage system	An assembly of sterile devices intended to be used for the aspiration of air/fluid from the pleural cavity (potential space between the serous membranes covering the lungs) by means of suction. It includes a pleural catheter, a water seal (underwater) drainage unit, typically with three separate chambers, and typically a suction system regulator, intended to be connected to the hospital's central vacuum system; it does not include pharmaceuticals. This system is usually used to restore normal lung function following chest or mediastinal surgery (e.g., open heart surgery), or to treat conditions such as pneumothorax and/or haemothorax. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JOL	CATHETER AND TIP, SUCTION

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: Yes
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: 624b7605-8f14-4e2c-bac4-e1d98cd9c86c
Public Version Date: December 06, 2023
Public Version Number: 3
DI Record Publish Date: December 22, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00812574020243	50	00812574025064		In Commercial Distribution

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: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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