AccessGUDID - DEVICE: Axiom® (M6651012250)

GUDID

Device Identifier (DI) Information

Brand Name: Axiom®
Version or Model: 101225
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AXIOM MEDICAL, INCORPORATED

Primary DI Number: M6651012250
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 094439676 *Terms of Use

Device Description: Penrose Tubing, Silicone

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?
43437	Surgical capillary wound drain, luminal, synthetic polymer	A sterile device with a lumen(s) designed to establish a passive egress for the removal of fluid (drainage of blood, lymph, exudate) from a surgical wound to minimize its accumulation and risk of wound infection; it is not dedicated to a particular anatomical wound. It is typically inserted into the wound by a surgeon in the operating room (OR) after the completion of an inpatient or outpatient procedure. It is typically made of radiopaque silicone and is available in various forms (e.g., Penrose type, tubular with side holes, multi-tubular). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KDH	Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K781749	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 12 Inch
Lumen/Inner Diameter: 0.25 Inch

Device Record Status

Public Device Record Key: b198c9d9-d67e-4754-9968-65095db096a6
Public Version Date: July 06, 2018
Public Version Number: 4
DI Record Publish Date: September 23, 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
M6651012253	10	M6651012251		In Commercial Distribution	Case
M6651012251	10	M6651012250		In Commercial Distribution	Box

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: 310-533-9020
Email: Sales@AxiomMed.com

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