FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 00607411917059
·
Model: ZCC4201MQF-1
·
SALTER LABS
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- N/A
- Primary DI
- 00607411917059
- Version / Model
- ZCC4201MQF-1
- Catalog Number
- ZCC4201MQF-1
- Company Name
- SALTER LABS
- Labeler DUNS
- 022721133
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-24
- Public Version
- 4
- Public Version Date
- 2019-05-29
- Public Version Status
- Update
- Public Device Record Key
- ab387888-f0aa-4b46-8723-5c068716e02b
Device Description
ComfortCheck Disposable Blood Pressure Cuff Adult (26-33cm) - Single Tube
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
- 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 |
|---|---|---|---|---|
| DXQ | blood pressure cuff | Cardiovascular | 870.1120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37326 | Blood pressure cuff, single-use | A band-like device that has an inflatable bladder in an inelastic sleeve with one or two connecting tubes with connector (typically locking connectors) that can be connected to a mechanism for inflating and deflating the bladder and/or a sphygmomanometer or a patient monitoring device/system that is used to determine a patient's blood pressure. It is typically wrapped around the upper arm of the patient. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00607411917059 | GS1 | ||||
| Package | 10607411917056 | GS1 | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)421-0024
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K921997 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Adult |