AccessGUDID - DEVICE: CP Stent™ (04046964899331)

GUDID

Device Identifier (DI) Information

Brand Name: CP Stent™
Version or Model: 614353
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 614353
Company Name: B BRAUN INTERVENTIONAL SYSTEMS, INC

Primary DI Number: 04046964899331
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 784259751 *Terms of Use

Device Description: CMCP004 Mounted Covered CP Stent 2.2 12

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
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?
43583	General aorta endovascular stent-graft	A non-bioabsorbable tubular device intended to be implanted in a non-specific region of the aorta to maintain aortic patency and improve luminal diameter in patients with symptomatic atherosclerotic disease or recurrent coarctation (narrowing) of the aorta. It is a mesh structure made of metal (e.g., platinum, iridium) that is covered with a synthetic polymer [e.g., polytetrafluoroethylene (ePTFE)] membrane (endovascular graft). It is typically expanded in situ (e.g., balloon-expandable) and disposable devices associated with implantation may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PNF	Aortic stent

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P150028	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 5 and 45 Degrees Celsius
Special Storage Condition, Specify:
Special Storage Condition, Specify: KEEP AWAY FROM SUNLIGHT

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Length : 22.000 MM
Device Size Text, specify: Diameter (mm) : 12.000 MM

Device Record Status

Public Device Record Key: 95e23448-b7b7-4984-b824-c2f825c2b050
Public Version Date: September 07, 2023
Public Version Number: 8
DI Record Publish Date: May 19, 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: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(877)836-2228
Email: GUDID.BBMUS_Service@bbraun.com

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