AccessGUDID - DEVICE: Spiration Valve System (00896506002125)

GUDID

Device Identifier (DI) Information

Brand Name: Spiration Valve System
Version or Model: HUS-SK
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Gyrus Acmi, Llc

Primary DI Number: 00896506002125
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117521967 *Terms of Use

Device Description: Airway Sizing Kit

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):	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?
58006	Endobronchial airway sizing kit	A sterile collection of mechanical devices intended to be used with a balloon catheter for a planned intervention to determine the appropriate endobronchial valve sizes for a patient's lung airways (bronchial lumens). It typically consists of a glass syringe and a plastic calibration gauge with holes representing available endobronchial valve sizes. The syringe is used for filling the balloon with a medium (e.g., sterile saline). Using the same balloon catheter, the volume reading on the syringe made with the balloon in the airway is compared against the volume readings taken with the calibration gauge to select the proper valve size needed for an airway. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OAZ	One-Way Air-Leak Valve

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
H060002	005

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
No Device Sizes

Device Record Status

Public Device Record Key: e9149823-bfd2-42a4-9f48-61c9c7ac62c2
Public Version Date: September 02, 2024
Public Version Number: 5
DI Record Publish Date: September 23, 2014

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

[?]

No Customer Contact currently defined

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