FDA UDI
In Commercial Distribution
🇺🇸 United States
Motion Medical Distributing
DI: 15060498450246
·
Model: 1709
·
Haslam Medical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Motion Medical Distributing
- Primary DI
- 15060498450246
- Version / Model
- 1709
- Catalog Number
- 1709
- Company Name
- Haslam Medical, Inc.
- Labeler DUNS
- 604208868
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-11
- Public Version
- 3
- Public Version Date
- 2018-10-22
- Public Version Status
- Update
- Public Device Record Key
- 8cf35d0d-69c7-47df-8dce-00bf0e938279
Device Description
Obstetrical Kit Contents: (2) Gloves L/F, (2) Umbilical Clamps, (1) Umbilical Scissor, (1) Receiving Blanket, (2) Sponge 4x4, (1) Bulb Syringe, (2) Towels 3-Ply, (1) Underpad 17x24, (2) Obstetrical Towelettes, (1) Obstetrical Pad, (1) Infant Diaper, (2) Twist Ties, (2) Nylon Ties, (1) Placenta Disposal Bag
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OKV | Obstetrical Kit | Obstetrics/Gynecology | 884.4520 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60644 | Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use | A collection of various sterile surgical instruments, dressings/drapes, and materials intended to be used during obstetrical/gynaecological surgery. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of obstetrical/gynaecological surgical procedure, but are often supplied together to perform a specific type of obstetrical/gynaecological procedure; it does not contain pharmaceuticals. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 25060498450243 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 15060498450246 | GS1 |