FDA UDI
In Commercial Distribution
🇺🇸 United States
Hu-Friedy
DI: 10889950002718
·
Model: IMS-1241
·
HU-FRIEDY MFG. CO., LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- Hu-Friedy
- Primary DI
- 10889950002718
- Version / Model
- IMS-1241
- Catalog Number
- IMS-1241
- Company Name
- HU-FRIEDY MFG. CO., LLC
- Labeler DUNS
- 005085972
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 4
- Public Version Date
- 2023-06-12
- Public Version Status
- Update
- Public Device Record Key
- 58dd3cfd-cc76-4dea-b7aa-8763e458c410
Device Description
IMS Integrator Strips (100/Pkg)
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| JOJ | Indicator, physical/chemical sterilization process | General Hospital | 880.2800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35362 | Chemical/physical sterilization process indicator | A sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change to one or more of the physical conditions within the chamber, to validate the sterilization process. It may be presented in one of a variety of forms (e.g., tape, test pack, tag). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10889950002718 | GS1 | ||||
| Unit of Use | 10889950075019 | GS1 |
Customer Contacts
- Phone
- +1(800)483-7433
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K213412 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 60 – 85 Degrees Fahrenheit