FDA UDI
In Commercial Distribution
🇺🇸 United States
AMC
DI: 00849593062152
·
Model: HO-S12368-10
·
Advantage Medical Electronics, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AMC
- Primary DI
- 00849593062152
- Version / Model
- HO-S12368-10
- Company Name
- Advantage Medical Electronics, LLC
- Labeler DUNS
- 080242300
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-02-27
- Public Version
- 4
- Public Version Date
- 2023-02-10
- Public Version Status
- Update
- Public Device Record Key
- e8ee9c7f-5170-4cf5-bb07-c3f50212705a
Device Description
NIBP Hose ,CN-BP12 and CN-BP36 Connectors,Gray-10'
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
- 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 |
|---|---|---|---|---|
| DXQ | Blood Pressure Cuff | Cardiovascular | 870.1120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62671 | External cuff/pad inflation tubing set, single-use | A collection of devices consisting of flexible tubes and connectors, which may also include supportive devices (e.g., clamp), intended to be used to deliver air from a pump to a noninvasive, patient-contact pad, pack, cuff, or cushion. It may be intended for use with a specific type of assembly. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00849593062152 | GS1 |
Customer Contacts
- Phone
- 954-345-9800
- [email protected]