FDA UDI
In Commercial Distribution
🇺🇸 United States
Hu-Friedy
DI: 10889950002145
·
Model: IMS-1345
·
HU-FRIEDY MFG. CO., LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
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Basic Information
- Brand Name
- Hu-Friedy
- Primary DI
- 10889950002145
- Version / Model
- IMS-1345
- Catalog Number
- IMS-1345
- 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
- 2020-11-06
- Public Version Status
- Update
- Public Device Record Key
- 9703b274-d2db-4b75-a8b2-0f53cbbc53a5
Device Description
IMS Bagette 13" x 20" 100 Pouches
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
- 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 |
|---|---|---|---|---|
| KCT | Sterilization wrap containers, trays, cassettes & other accessories | General Hospital | 880.6850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58968 | Instrument management bag | A flexible plastic container intended to hold/collect instruments, cables, or other equipment during a surgical procedure or other clinical intervention, typically being attached to a drape or other support close to or inside the sterile field of operation/intervention. It may have a variety of designs, e.g., number of pouches, adhesive/non-adhesive, overall shape and size. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10889950002145 | GS1 | ||||
| Unit of Use | 10889950035334 | GS1 |
Customer Contacts
- Phone
- +1(800)483-7433
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K070428 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- High: 70 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 95 Degrees Fahrenheit