FDA UDI
In Commercial Distribution
🇺🇸 United States
ACCU-CHECK GUIDE
DI: 00365702703254
·
Model: 10439238001
·
Roche Diagnostics Operations, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
2
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Basic Information
- Brand Name
- ACCU-CHECK GUIDE
- Primary DI
- 00365702703254
- Version / Model
- 10439238001
- Catalog Number
- 10439238001
- Company Name
- Roche Diagnostics Operations, Inc.
- Labeler DUNS
- 141608724
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2025-03-20
- Public Version
- 1
- Public Version Date
- 2025-03-28
- Public Version Status
- New
- Public Device Record Key
- 5c199778-f4de-4253-999a-1d8d6d8553a4
Device Description
ACCU-CHEK GUIDE CASH US 60CT STRIP
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
- 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 |
|---|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | Clinical Chemistry | 862.1345 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53307 | Glucose IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of glucose in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10365702703251 | GS1 | 24 | In Commercial Distribution | ||
| Primary | 00365702703254 | GS1 | ||||
| Unit of Use | 50365702703259 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160944 | 000 |