AccessGUDID - DEVICE: Life-Stat (00860682000121)

GUDID

Device Identifier (DI) Information

Brand Name: Life-Stat
Version or Model: 1008MII
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 16000
Company Name: MICHIGAN INSTRUMENTS, LLC

Primary DI Number: 00860682000121
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081208064 *Terms of Use

Device Description: External Cardiac Compressor - Life-Stat Model 1008MII

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):	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?
45748	Cardiac resuscitator, pneumatic	A pneumatically-powered external device designed for the application of rhythmic compression to the chest in the region of the heart to provide blood flow during treatment of cardiac arrest [cardiopulmonary resuscitation (CPR)]. It is typically powered from medical gas cylinders or a medical gas pipeline system and may consist of a solid base with an attached band that straps across the patient's chest to produce the compressions, or have other configurations. The device is typically used as an adjunct to or substitute for manual external cardiac compression, to prevent fatigue and to provide better consistency in the applied force and rate of compression.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DRM	Compressor, Cardiac, External

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K073079	000

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: cea8dcaa-138f-4f69-9c92-b4389b600263
Public Version Date: July 11, 2023
Public Version Number: 5
DI Record Publish Date: September 12, 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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 616-554-9696
Email: mii@michinst.com

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