FDA UDI
In Commercial Distribution
🇺🇸 United States
DELTRAN
DI: H671ABC248A0
·
Model: PLUS ABC KIT
·
UTAH MEDICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- DELTRAN
- Primary DI
- H671ABC248A0
- Version / Model
- PLUS ABC KIT
- Catalog Number
- ABC-248A
- Company Name
- UTAH MEDICAL PRODUCTS, INC.
- Labeler DUNS
- 094651270
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2019-12-18
- Public Version Status
- Update
- Public Device Record Key
- f9197e9f-a14b-40ea-85d9-a2140e8c94dd
Device Description
Disposable Pressure Transducer System, 3cc/hr Flow Rate with Arterial Blood Collection System, 48/12", Macro Drip Chamber, 3cc Reservoir
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CBT | Arterial Blood Sampling Kit | Anesthesiology | 868.1100 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45760 | In-line arterial blood sampling set | A collection of sterile devices designed to obtain an in-line arterial blood specimen while maintaining a closed system. It is a haemodynamic pressure monitoring and blood gas sampling device, typically designed for use with disposable/reusable pressure transducers, intended to connect to a central line/arterial catheter from which the blood specimen is obtained. Heparinized blood may be reinfused into the patient via the device to reduce fluid loss. This is a single-patient device that may be used short term (single-use) before being discarded. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | H671ABC248A1 | HIBCC | Box | 25 | In Commercial Distribution | |
| Primary | H671ABC248A0 | HIBCC |
Customer Contacts
- Phone
- 800-533-4984
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Flow Rate - 3 cc/hr |