AccessGUDID - DEVICE: n/a (00874750006540)

GUDID

Device Identifier (DI) Information

Brand Name: n/a
Version or Model: 3850
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 112587
Company Name: HANS RUDOLPH, INC.

Primary DI Number: 00874750006540
Issuing Agency: GS1
Commercial Distribution End Date: June 30, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 007131725 *Terms of Use

Device Description: 3850AF PNT HTR CNTRL 230V 50HZ

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:	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?
35245	Pneumotachograph	A device designed to graphically record the instantaneous flow (velocity) of air at the mouth or, using an integrated signal, the volume of air per breath during inspiration or expiration. This recorder consists of a resistance attachment (e.g., wire screen or capillary tubes) placed in a tube in which the respiratory gases flow, the pressure drop being linearly related to airflow velocity. It is used for displaying the dynamics of respiration, and also can be used, in conjunction with an oesophageal balloon, to measure static lung compliance or airway resistance in conjunction with a whole-body plethysmograph.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JAX	Pneumotachometer

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: c6eb9d09-6b25-49d1-88f1-de276c4af19d
Public Version Date: June 30, 2023
Public Version Number: 5
DI Record Publish Date: September 16, 2016

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: Yes
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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