FDA UDI
In Commercial Distribution
🇺🇸 United States
American Hospital Supply
DI: 00850037921638
·
Model: AHSPIB3000_CS
·
American Hospital Supply LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
80
Basic Information
- Brand Name
- American Hospital Supply
- Primary DI
- 00850037921638
- Version / Model
- AHSPIB3000_CS
- Catalog Number
- AHSPIB3000_CS
- Company Name
- American Hospital Supply LLC
- Labeler DUNS
- 118098262
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 80
- Record Status
- Published
- Publish Date
- 2023-02-17
- Public Version
- 1
- Public Version Date
- 2023-02-27
- Public Version Status
- New
- Public Device Record Key
- 01262ff3-17c1-49ac-bea3-f18fdc153d4c
Device Description
AHS Pressure Infusion Bag | 3000 mL |Case of 80
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
- No
- 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
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KZD | Infusor, Pressure, For I.V. Bags | General Hospital | 880.5420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65172 | Intravenous pressure infusor, manual, single-use | A manually-operated device designed to increase/control the rate of an intravenous (IV) solution given to a patient by manually applying pressure directly to the infusion bag. It is typically a flexible inflatable bag/cuff with a pocket to hold the infusion bag; it may include a squeeze bulb, mechanical screw, or spring mechanism to create the pressure. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00850046814396 | GS1 | ||||
| Primary | 00850037921638 | GS1 |
Customer Contacts
- Phone
- 888-621-5011
- [email protected]