AccessGUDID - DEVICE: Hands Free Syringe (00814384020406)

GUDID

Device Identifier (DI) Information

Brand Name: Hands Free Syringe
Version or Model: HFS-PDL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 411983-001
Company Name: CONCERT MEDICAL, LLC

Primary DI Number: 00814384020406
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 189689800 *Terms of Use

Device Description: 1 Foot pedal unit that controls injection/aspiration of HFS Sterile Syringe.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	No
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?
58506	Pain management medication delivery system	An assembly of devices intended to be used by a healthcare professional (e.g., orthopaedist, pain management specialist, rheumatologist) for the intermittent delivery of liquid medication in a controlled manner to manage pain in various applications [e. g, intra-articular, epidural site(s), and nerve blocks]. It typically consists of a mains electricity (AC-powered) multichannel delivery pump, a disposable cassette, vial transfer spikes, and a handpiece/tubing set. The system automates aspects of the injection procedure otherwise performed by manual syringe and typically records treatment information for patient records; it may interface with an external ultrasound (US) system.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRN	Pump, Infusion

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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
Storage Environment Atmospheric Pressure: between 500 and 1060 millibar
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -40 and 120 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e2a3c199-9f7b-46c9-ba22-f6d914b24375
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: January 06, 2017

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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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