FDA UDI
In Commercial Distribution
🇺🇸 United States
DOPPLEX
DI: 05051968013408
·
Model: ACC185
·
HUNTLEIGH HEALTHCARE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- DOPPLEX
- Primary DI
- 05051968013408
- Version / Model
- ACC185
- Catalog Number
- ACC185
- Company Name
- HUNTLEIGH HEALTHCARE LIMITED
- Labeler DUNS
- 217207083
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-19
- Public Version
- 4
- Public Version Date
- 2019-07-22
- Public Version Status
- Update
- Public Device Record Key
- 7c5ae3eb-bd45-4fbc-822b-c5f54106e4a3
Device Description
DIGT/TOE CUFF KIT+COLDER(3LG+3STD)
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
- 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 |
|---|---|---|---|---|
| KNG | Monitor, Ultrasonic, Fetal | Obstetrics/Gynecology | 884.2660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34978 | Blood pressure cuff, reusable | 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 wrapped around the upper arm or the leg (thigh) of the patient. This is a reusable device which may be intended for single-patient or multi-patient reuse. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05051968013408 | GS1 |
Customer Contacts
- Phone
- +4402920485885
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K930200 | 000 |
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 860 – 1060 millibar
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 860 – 1060 millibar
- Type
- Storage Environment Humidity
- Temperature Range
- – 93 Percent (%) Relative Humidity
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 40 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius