FDA UDI
In Commercial Distribution
🇺🇸 United States
AutoPulse®Resuscitation System
DI: 00849111003223
·
Model: Shoulder Restraint English
·
Zoll Circulation, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AutoPulse®Resuscitation System
- Primary DI
- 00849111003223
- Version / Model
- Shoulder Restraint English
- Catalog Number
- 8700-0709
- Company Name
- Zoll Circulation, Inc.
- Labeler DUNS
- 799455241
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-15
- Public Version
- 1
- Public Version Date
- 2022-08-23
- Public Version Status
- New
- Public Device Record Key
- 75f53f81-74ec-40f3-9701-1912b4ac313c
Device Description
Shoulder Restraint English
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| 61908 | Cardiac resuscitator, battery-powered | A battery-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 may be available in a variety of forms but includes a mechanical chest compressor (e.g., plunger-type), a battery-powered control unit, and patient straps/supports. The device is typically used as an adjunct to or substitute for manual external cardiac compression in cases where manual compression is not ideal, or to prevent fatigue and improve consistency (i.e., of force, rate). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00849111003223 | GS1 |
Customer Contacts
- Phone
- 4085412140
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K112998 | 000 |