FDA UDI
In Commercial Distribution
🇺🇸 United States
Defibtech ACC Wrist Straps
DI: 00815098020669
·
Model: RSS-1010
·
DEFIBTECH, L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- Defibtech ACC Wrist Straps
- Primary DI
- 00815098020669
- Version / Model
- RSS-1010
- Company Name
- DEFIBTECH, L.L.C.
- Labeler DUNS
- 128340200
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-19
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- f7fcb3e5-66eb-4037-82eb-84d78e1ea2fe
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
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| 44780 | Cardiac resuscitator, line-powered | A mains electricity (AC-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)]. The device 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 |
|---|---|---|---|---|---|---|
| Package | 20815098020687 | GS1 | export configuration | 3 | In Commercial Distribution | |
| Primary | 00815098020669 | GS1 | ||||
| Package | 10815098020680 | GS1 | export configuration | 1 | In Commercial Distribution | |
| Package | 10815098020673 | GS1 | domestic configurati | 1 | In Commercial Distribution | |
| Package | 20815098020670 | GS1 | domestic configurati | 3 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141809 | 000 |