FDA UDI
In Commercial Distribution
🇺🇸 United States
Sherlock
DI: 00801741124334
·
Model: 9770003
·
Bard Access Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Sherlock
- Primary DI
- 00801741124334
- Version / Model
- 9770003
- Catalog Number
- 9770003
- Company Name
- Bard Access Systems, Inc.
- Labeler DUNS
- 044611812
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-15
- Public Version
- 3
- Public Version Date
- 2020-05-19
- Public Version Status
- Update
- Public Device Record Key
- 1363a7f2-99a1-4754-8a85-a7855eaa0c97
Device Description
Sensor, TLS II, Sherlock
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| LJS | Catheter,intravascular,therapeutic,long-term greater than 30 days | General Hospital | 880.5970 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44119 | Intravascular catheter stylet magnet detector | An electrically-powered device designed to rapidly detect and confirm the location and orientation of the tip of a compatible, peripherally-inserted central catheter (PICC) or central venous catheter (CVC) stylet containing one or more small, specially-oriented magnets encapsulated at the distal end. It provides rapid feedback to healthcare personnel on the positioning of the catheter/stylet during initial placement. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00801741124334 | GS1 |
Customer Contacts
- Phone
- +1(800)545-0890
- [email protected]
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -18 – 40 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 18 – 106 KiloPascal