AccessGUDID - DEVICE: HemoBand (00865165000223)

GUDID

Device Identifier (DI) Information

Brand Name: HemoBand
Version or Model: HB-1M
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HB-1M
Company Name: INNOVATIONS FOR ACCESS INC

Primary DI Number: 00865165000223
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 051632466 *Terms of Use

Device Description: HemoBand Sterile HB-1M (Standard Length - 14")

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?
65119	Vascular puncture haemostasis arm clamp/band, single-use	A semi-flexible, adjustable, clamp or band/strap device designed for application over an arterial/venous/fistula needle-puncture site on a patient’s arm to provide uniform pressure and achieve haemostasis. Commonly used on haemodialysis patients, some types are referred to as fistula clamps. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KOC	Accessories, Blood Circuit, Hemodialysis

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K920614	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: 14 Inch

Device Record Status

Public Device Record Key: afc82cd5-11bb-4cd0-96ac-5e6c7a323859
Public Version Date: October 22, 2020
Public Version Number: 3
DI Record Publish Date: September 03, 2020

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

[?]

Phone: 1-800-297-8485
Email: orders@hemoband.net

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