AccessGUDID - DEVICE: SU-VEID (07290018896136)

GUDID

Device Identifier (DI) Information

Brand Name: SU-VEID
Version or Model: 18103200
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 18103200
Company Name: ANGIE TECHNOLOGIES LTD

Primary DI Number: 07290018896136
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600634887 *Terms of Use

Device Description: Package of 30 SU-VEID units (DI# 07290018896037)

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?
62900	Invasive-detection multi-parameter physiological monitor, single-use	An electronic device intended for the continuous or intermittent measurement and display of several invasively-detected physiological parameters (e.g., intracranial, compartmental, and blood pressures). It consists of a single unit intended to be used with an invasive access device(s) [e.g., catheter, syringe, needle] (not included) to which it is connected; its use is not dedicated to a specific type of procedure. It typically has proximal and distal connection points for the specific connecting elements, a digital display screen, and controls. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMF	Syringe, Piston

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K993995	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

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: 56c6d7ba-fb2f-41c9-ac0c-1f83aa396620
Public Version Date: May 31, 2021
Public Version Number: 1
DI Record Publish Date: May 23, 2021

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: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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