AccessGUDID - DEVICE: Early Bird Bleed Monitoring System (00866532000402)

GUDID

Device Identifier (DI) Information

Brand Name: Early Bird Bleed Monitoring System
Version or Model: FG001-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SARANAS INC.

Primary DI Number: 00866532000402
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078299103 *Terms of Use

Device Description: No description.

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:	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?
15023	Femoral artery/vein access catheter	A thin, flexible tube intended to be surgically inserted into the femoral artery or the femoral vein to provide an alternative access to a patient's vasculature, typically when other access routes are not viable or are exhausted. It may be used for continuous arteriovenous (AV) haemofiltration, the delivery of chemotherapeutic agents, or for other chronic applications to avoid repetitive injections. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QFJ	Intravascular Bleed Monitor

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN180021	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
Device Size Text, specify: 6 French

Device Record Status

Public Device Record Key: 331bb107-c044-47b1-aed2-94beb2eb6cb0
Public Version Date: December 11, 2019
Public Version Number: 2
DI Record Publish Date: November 19, 2019

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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 18333759273
Email: info@saranas.com

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