FDA UDI
In Commercial Distribution
🇺🇸 United States
Life-Stat
DI: 00860682000121
·
Model: 1008MII
·
MICHIGAN INSTRUMENTS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Life-Stat
- Primary DI
- 00860682000121
- Version / Model
- 1008MII
- Catalog Number
- 16000
- Company Name
- MICHIGAN INSTRUMENTS, LLC
- Labeler DUNS
- 081208064
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-12
- Public Version
- 5
- Public Version Date
- 2023-07-11
- Public Version Status
- Update
- Public Device Record Key
- cea8dcaa-138f-4f69-9c92-b4389b600263
Device Description
External Cardiac Compressor - Life-Stat Model 1008MII
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DRM | Compressor, Cardiac, External | Cardiovascular | 870.5200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860682000121 | GS1 |
Customer Contacts
- Phone
- 616-554-9696
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K073079 | 000 |