FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Posey
DI: 00618125191550
·
Model: 8235NCHH
·
TIDI PRODUCTS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
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Basic Information
- Brand Name
- Posey
- Primary DI
- 00618125191550
- Version / Model
- 8235NCHH
- Catalog Number
- 8235NCHH
- Company Name
- TIDI PRODUCTS, LLC
- Labeler DUNS
- 063519193
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-03
- Public Version
- 2
- Public Version Date
- 2024-12-13
- Public Version Status
- Update
- Public Device Record Key
- 985dd606-6219-4733-baae-782d70cfcc1e
- Distribution End Date
- 2024-12-12
Device Description
NC CBL & DUKANE ADPTER
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| KMI | Monitor, Bed Patient | General Hospital | 880.2400 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62165 | Nurse call system | An assembly of electronic devices, integrated within a facility infrastructure and/or wireless network, designed to provide an audio/visual signal to summon help when activated in response to a patient’s need for (urgent) assistance. It typically consists of and/or interacts with user- or sensor-activated signal transmitters (e.g., patient-worn pendant, push-buttons, microphones, speakers, fall sensors, smoke alarm, door sensors), a network communicator, and alert communication devices (e.g., server computer, phone, dome lights, audible alarm). The device notifies medical professionals and caregivers and is intended for use in the healthcare facility. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10618125191557 | GS1 | Box | 1 | Not in Commercial Distribution | 2024-12-12 |
| Primary | 00618125191550 | GS1 | ||||
| Package | 20618125191554 | GS1 | Case | 24 | Not in Commercial Distribution | 2024-12-12 |
| Previous | 10190676003959 | GS1 |