FDA UDI
In Commercial Distribution
🇺🇸 United States
Sapphire
DI: 10887787007524
·
Model: 1639302
·
ICU MEDICAL FLEET SERVICES, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Sapphire
- Primary DI
- 10887787007524
- Version / Model
- 1639302
- Catalog Number
- 1639302
- Company Name
- ICU MEDICAL FLEET SERVICES, LLC
- Labeler DUNS
- 830767898
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-01
- Public Version
- 2
- Public Version Date
- 2018-07-06
- Public Version Status
- New
- Public Device Record Key
- b75e8a67-ae3c-4ac3-88ad-1246ab0bbaf2
Device Description
SAPPHIRE Primary Polyethylene Lined Light Resistant Set Microbore, 121 Inch
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
- Yes
- 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 |
|---|---|---|---|---|
| MRZ | ACCESSORIES, PUMP, INFUSION | General Hospital | 880.5725 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35833 | Electric infusion pump administration set, single-use | A collection of sterile devices (e.g., plastic tubing, check valve, roller clamp, Y-site connector, Luer, needle/catheter) intended to be used in combination with an electrically-powered infusion pump for the intravenous (IV), subcutaneous, intramuscular, or epidural administration of medication. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20887787007521 | GS1 | Corrugated Box | 50 | In Commercial Distribution | |
| Primary | 10887787007524 | GS1 | ||||
| Secondary | M33516393020 | HIBCC |
Customer Contacts
- Phone
- +1(877)946-7747
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K171346 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Approximate priming volume : 4.1 Milliliter | ||
| Length | 121 | Inch |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Room Temperature. Avoid Excessive Heat. Protect from Freezing