FDA UDI
In Commercial Distribution
🇺🇸 United States
CMI
DI: H671506TTL0
·
Model: Ultra Cup
·
UTAH MEDICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CMI
- Primary DI
- H671506TTL0
- Version / Model
- Ultra Cup
- Catalog Number
- 506TTL
- 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
- 5
- Public Version Date
- 2019-12-18
- Public Version Status
- Update
- Public Device Record Key
- b669daf7-db07-400b-888c-6ef5d71f54bc
Device Description
OBSTETRICAL VACUUM DELIVERY KIT, 65mm Ultra Cup, x/ 6' Tube, Adapter, Vacuum Relief Valve
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 |
|---|---|---|---|---|
| HIS | Condom | Obstetrics/Gynecology | 884.5300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37792 | Foetal vacuum extraction system cup, single-use | A suction cap intended to be applied to the scalp of a foetus to facilitate vaginal or Caesarean section delivery by traction. It typically has a soft liner to prevent tissue damage, a connection to the vacuum source, a handgrip for the clinician to apply traction, and may include a vacuum release valve and fluid retention trap. Suction may be provided by an electrically-powered suction pump, the hospital central vacuum system, or a hand-operated vacuum pump. It is typically used for dystocia, uterine inertia, maternal exhaustion, or maternal/foetal distress. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | H671506TTL1 | HIBCC | Box | 10 | In Commercial Distribution | |
| Primary | H671506TTL0 | HIBCC |
Customer Contacts
- Phone
- 800-533-4984
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K910788 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 65 | Millimeter |