FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 00085412624839
·
Model: ADS201816
·
BAXTER HEALTHCARE CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 00085412624839
- Version / Model
- ADS201816
- Catalog Number
- ADS201816
- Company Name
- BAXTER HEALTHCARE CORPORATION
- Labeler DUNS
- 005083209
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-01-28
- Public Version
- 4
- Public Version Date
- 2023-08-10
- Public Version Status
- Update
- Public Device Record Key
- 496fee83-01b3-459f-af56-237be2ad7f14
Device Description
13cm Malleable Applicator Tip
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KGZ | ACCESSORIES, CATHETER | General, Plastic Surgery | 878.4200 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47186 | Haematological concentrate/haemostatic agent applicator | A hand-held, manually-operated device designed to administer, in a liquid or spray form, a haematological concentrate and/or haemostatic agent (e.g., thrombin, platelet concentrate, plant polysaccharide) to a surgical wound, lesion, or graft during surgery (open and/or endoscopic), typically to facilitate haemostasis and healing. It is typically a syringe-/plunger-like, single-channel or dual-channel (for co-administration of two separate agents) device, which may also be designed for connection to a gas pump for spraying. Delivery cannula(s)/tip(s) may be included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20085412624833 | GS1 | PACK_OR_INNER_PACK | 6 | In Commercial Distribution | |
| Primary | 00085412624839 | GS1 | ||||
| Package | 50085412624834 | GS1 | CASE | 4 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(888)229-0001
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 25 Degrees Celsius