FDA UDI
In Commercial Distribution
🇺🇸 United States
Mission Plus Hemoglobin (Hb) Monitoring System
DI: 00682607611140
·
Model: C112-3061
·
ACON LABORATORIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Mission Plus Hemoglobin (Hb) Monitoring System
- Primary DI
- 00682607611140
- Version / Model
- C112-3061
- Company Name
- ACON LABORATORIES, INC.
- Labeler DUNS
- 781100966
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 11c1e01a-8737-4a35-b267-6877bc1874ad
Device Description
Hb meter, 100 Test Cartridges, 120 Capillary Transfer Tubes, 2 Optical Verifiers
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GKR | SYSTEM, HEMOGLOBIN, AUTOMATED | Hematology | 864.5620 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32435 | Haemoglobin analyser IVD, point-of-care | A mains electricity (AC-powered) instrument, which may include internal rechargeable batteries, intended to be used by health professionals at the point-of-care, and often also in the laboratory, to determine the concentration of haemoglobin in a clinical specimen, using technology which may include colorimetry, electrometry or photometry. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | 00682607000180 | GS1 | ||||
| Package | 20682607611144 | GS1 | carton | 12 | In Commercial Distribution | |
| Primary | 00682607611140 | GS1 |
Customer Contacts
- Phone
- +1(800)838-9502 ext. 1
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K122553 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep out of direct sunlight
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a cool, dry place
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 86 Degrees Fahrenheit