AccessGUDID - DEVICE: DuraMax (H787103028240)

GUDID

Device Identifier (DI) Information

Brand Name: DuraMax
Version or Model: 10302824
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ANGIODYNAMICS, INC.

Primary DI Number: H787103028240
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079105071 *Terms of Use

Device Description: 15.5F x 55cm Chronic Hemodialysis VascPak Kit (with Cuff 50cm from Tip)

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":	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?
37278	Double-lumen haemodialysis catheter, implantable	An implantable, flexible, double-lumen tube intended to be used for chronic or long-term (> 30 days) vascular access, primarily during haemodialysis, to conduct blood from a patient and returning it after extracorporeal circulation; it may also be used during haemoperfusion and/or apheresis. It is intended for coaxial flow of blood, may be radiopaque, coated with heparin to prevent thrombus formation, and/or include a silver-coated sleeve to retard bacterial growth; devices dedicated to catheter introduction/function (e.g., introducer needle) may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MSD	Catheter, hemodialysis, implanted

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K101843	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: less than 27 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 15.5 French
Length: 55 Centimeter

Device Record Status

Public Device Record Key: 967623f9-8005-4a5e-9c70-a1dafff27f1f
Public Version Date: February 05, 2021
Public Version Number: 5
DI Record Publish Date: September 15, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
H787103028245	1	H787103028240		In Commercial Distribution	BOX

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
GS1	15051684011983

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(518)795-1676
Email: dgreer@angiodynamics.com

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