AccessGUDID - DEVICE: HCS (00849027003805)

GUDID

Device Identifier (DI) Information

Brand Name: HCS
Version or Model: HCS1320Y
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DYAD MEDICAL SOURCING, LLC

Primary DI Number: 00849027003805
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 500
Labeler D-U-N-S® Number*: 078572603 *Terms of Use

Device Description: Patient ID Band, Yellow "Fall Risk” Alert

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):	No
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?
32048	Patient identification band	A single-piece circular band designed to be worn around the wrist (i.e., bracelet, wristband), or sometimes ankle in babies, to provide identification and basic information about a patient. It is typically a slender, thin, and soft plastic band, with a self-locking device, that usually includes printed information with the name, date of birth, patient registration number, and other data that permit clear and easy identification of a patient in the healthcare facility. Some devices also include bar-code information intended for reading with a computerized reader/scanner.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FZZ	Marker, Skin

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: c073b3e4-01c4-41f4-85f4-240938b85711
Public Version Date: September 08, 2020
Public Version Number: 1
DI Record Publish Date: August 31, 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
10849027003802	10	00849027003805		In Commercial Distribution	case

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 20849027003809 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: No
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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