FDA UDI
In Commercial Distribution
🇺🇸 United States
BT-CATH
DI: H671BTCESY0
·
Model: EasyFill
·
UTAH MEDICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- BT-CATH
- Primary DI
- H671BTCESY0
- Version / Model
- EasyFill
- Catalog Number
- BTC-ESY
- 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
- 4
- Public Version Date
- 2019-12-18
- Public Version Status
- Update
- Public Device Record Key
- c2e92c6b-ab57-412c-bdff-6a6ca9f2880c
Device Description
Balloon Tamponade Catheter for Postpartum Uterine Hemorrhage with EasyFill Inflation System
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| OQY | Intrauterine Tamponade Balloon | Obstetrics/Gynecology | 884.4530 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12155 | Intrauterine haemostatic balloon catheter | A sterile, flexible tube with an inflatable balloon at its distal end intended to be inserted into the uterus and distended with a medium (e.g., sterile water, medical air or other appropriate gas) to reduce postpartum bleeding with pressure. It may have an additional balloon inflated in the upper vagina to seal the uterine cavity. Devices associated with balloon inflation may be included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | H671BTCESY1 | HIBCC | Box | 2 | In Commercial Distribution | |
| Primary | H671BTCESY0 | HIBCC |
Customer Contacts
- Phone
- 800-533-4984
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K101535 | 000 |