AccessGUDID - DEVICE: Curaplex (00815277020633)

GUDID

Device Identifier (DI) Information

Brand Name: Curaplex
Version or Model: 2525-16050
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BOUND TREE MEDICAL, LLC

Primary DI Number: 00815277020633
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070556204 *Terms of Use

Device Description: Curaplex ALS Pedi Kit For University Hosp of Cleveland

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):	Yes
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?
43000	First aid kit, non-medicated, reusable	A convenient collection of equipment and materials intended to be used in an emergency for the rapid, initial treatment of an injury. This device is typically used by emergency medical services (EMS), institutions, schools, the home, motor vehicles, and other public settings. This device does not contain medicinal substances/pharmaceuticals. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMF	Syringe, piston
MMK	Container, sharps
DRX	Electrode, electrocardiograph
DXQ	blood pressure cuff
BTM	Ventilator, emergency, manual (resuscitator)
FPB	Filter, infusion line
CCK	ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
GJE	TRAY, BLOOD COLLECTION
POQ	Blood transfusion kit
FHM	APPARATUS, SUTURING, STOMACH AND INTESTINAL
BTR	Tube, tracheal (w/wo connector)
PEZ	Central venous catheter dressing change kit
FMI	Needle, hypodermic, single lumen

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: bac900c9-c23a-484b-9ffc-fe4a33f37c4f
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: December 14, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

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: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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