Floyd Aorta Pack
- Primary DI
- 00817395020175
- Brand
- Floyd Aorta Pack
- Company
- PACKROOM LLC
- Model
- FM110
- Device description
- Floyd Aorta Pack
- Published
- 2018-09-24
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- true
- Single use
- true
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00817395020175 | Primary | GS1 | 0 | |
GMDN Terms
| Term | Definition |
|---|
| General/plastic surgical procedure kit, non-medicated, single-use | A collection of various sterile surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. This is a single-use device. |
Regulatory Flags
- DUNS number
- 015179820
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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| 00817395024098 | Kit, Ped Nurse Blue 19-23kg NGHS | KT7700BIV.003 | | 2024-06-25 |
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| 00817395024111 | Kit, Ped Nurse Green 30-36kg NGHS | KT7700GIV.002 | | 2024-06-25 |
| 00817395024128 | Kit, Ped Intub Orange 24-29kg NGHS | KT7700OIN.004 | | 2024-06-25 |
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| 00817395024142 | Kit, Ped Intub Purple 10-11kg NGHS | KT7700PIN.005 | | 2024-06-25 |
| 00817395024159 | Kit, Ped Nurse Purple 10-11kg NGHS | KT7700PIV.001 | | 2024-06-25 |
| 00817395024166 | Kit, Ped Intub Pink/Red 6-9kg NGHS | KT7700RIN.007 | | 2024-06-25 |
| 00817395024173 | Kit, Ped Nurse White 15-18kg NGHS | KT7700WIV.002 | | 2024-06-25 |
| 00817395024180 | Kit, Ped Intub Yellow 12-14kg NGHS | KT7700YIN.005 | | 2024-06-25 |
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