AccessGUDID - DEVICE: Assy, 25' Pulmo Chest Bellows (00851607003112)

GUDID

Device Identifier (DI) Information

Brand Name: Assy, 25' Pulmo Chest Bellows
Version or Model: A01A103LONG
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDSPIRA, LLC

Primary DI Number: 00851607003112
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962187964 *Terms of Use

Device Description: Assy, 25' Pulmo Chest Bellows

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
56624	Breath-hold system patient belt, pneumatic	A non-sterile component of a breath-hold system that operates pneumatically and is designed to be worn around the chest or abdomen of the patient to detect movement during the respiratory cycle. It is connected to the system's base station where motion measuring devices (e.g., transducers) translate pneumatic pressures into electronic values. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HCC	Device, Biofeedback

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 107e8ec8-6d20-4815-8acb-ebc15b2148a5
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 20, 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
10851607003119	1	00851607003112		In Commercial Distribution	shipper

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

Customer Contact

[?]

Phone: 612-789-0013
Email: info@medspira.com

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