Telfa 12388AMD
GUDID 20884521154084
AMD Antimicrobial Non-adherent Dressing,0.2% Polyhexamethylene Biguanide HCI (PHMB)
Cardinal Health, Inc.
Wound-nonadherent dressing, absorbent, sterile| Primary Device ID | 20884521154084 |
| NIH Device Record Key | 49c61c2a-c0d8-4152-8042-244a7f06a023 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Telfa |
| Version Model Number | 12388AMD |
| Catalog Number | 12388AMD |
| Company DUNS | 080935429 |
| Company Name | Cardinal Health, Inc. |
| Device Count | 200 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com | |
| Phone | +1(508)261-8000 |
| covidien.udi@covidien.com |
Device Dimensions
| Length | 8 Inch |
| Width | 3 Inch |
| Length | 8 Inch |
| Width | 3 Inch |
| Length | 8 Inch |
| Width | 3 Inch |
| Length | 8 Inch |
| Width | 3 Inch |
| Length | 8 Inch |
| Width | 3 Inch |
| Length | 8 Inch |
| Width | 3 Inch |
| Length | 8 Inch |
| Width | 3 Inch |
| Length | 8 Inch |
| Width | 3 Inch |
| Length | 8 Inch |
| Width | 3 Inch |
| Length | 8 Inch |
| Width | 3 Inch |
| Length | 8 Inch |
| Width | 3 Inch |
| Length | 8 Inch |
| Width | 3 Inch |
| Length | 8 Inch |
| Width | 3 Inch |
| Length | 8 Inch |
| Width | 3 Inch |
| Length | 8 Inch |
| Width | 3 Inch |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *This side up; |
| Special Storage Condition, Specify | Between 0 and 0 *This side up; |
| Special Storage Condition, Specify | Between 0 and 0 *This side up; |
| Special Storage Condition, Specify | Between 0 and 0 *This side up; |
| Special Storage Condition, Specify | Between 0 and 0 *This side up; |
| Special Storage Condition, Specify | Between 0 and 0 *This side up; |
| Special Storage Condition, Specify | Between 0 and 0 *This side up; |
| Special Storage Condition, Specify | Between 0 and 0 *This side up; |
| Special Storage Condition, Specify | Between 0 and 0 *This side up; |
| Special Storage Condition, Specify | Between 0 and 0 *This side up; |
| Special Storage Condition, Specify | Between 0 and 0 *This side up; |
| Special Storage Condition, Specify | Between 0 and 0 *This side up; |
| Special Storage Condition, Specify | Between 0 and 0 *This side up; |
| Special Storage Condition, Specify | Between 0 and 0 *This side up; |
| Special Storage Condition, Specify | Between 0 and 0 *This side up; |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 20884521154084 [Package] Contains: 30884521154081 Package: CASE [4000 Units] In Commercial Distribution |
| GS1 | 30884521154081 [Primary] |
| GS1 | 40884521154088 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K011941
FDA Product Code
| EFQ | GAUZE/SPONGE, INTERNAL |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-02-15 |
| Device Publish Date | 2018-06-29 |
On-Brand Devices [Telfa]
| 00884521068141 | Adhesive Island Dressing |
| 00884521065454 | Adhesive Island Dressing |
| 00884521027001 | AMD Antimicrobial Non-adherent Island Dressing,0.2% Polyhexamethylene Biguanide HCI (PHMB) |
| 00884521026981 | AMD Antimicrobial Non-adherent Island Dressing,0.2% Polyhexamethylene Biguanide HCI (PHMB) |
| 00884521026950 | AMD Antimicrobial Non-adherent Island Dressing,0.2% Polyhexamethylene Biguanide HCI (PHMB) |
| 00884521026929 | AMD Antimicrobial Non-adherent Island Dressing,0.2% Polyhexamethylene Biguanide HCI (PHMB) |
| 00884521026882 | AMD Antimicrobial Non-adherent Pad,0.2% Polyhexamethylene Biguanide HCI (PHMB) |
| 00884521026868 | AMD Antimicrobial Non-adherent Pad,0.2% Polyhexamethylene Biguanide HCI (PHMB) |
| 20884521154084 | AMD Antimicrobial Non-adherent Dressing,0.2% Polyhexamethylene Biguanide HCI (PHMB) |
| 10884521065253 | Non-adherent Clear Wound Dressing |
| 10884521532571 | Non-adherent Clear Wound Dressing |
| 10884521532564 | Non-adherent Clear Wound Dressing |
| 30884521065233 | Non-adherent Clear Wound Dressing |
| 10884521105669 | Non-adherent Dressing |
| 20884527022509 | Clear Wound Dressing |
| 30884521065356 | Plus Barrier Island Dressing |
| 40884521065346 | Plus Barrier Island Dressing |
| 30884521065332 | Plus Barrier Island Dressing |
| 30884521065325 | Plus Barrier Island Dressing |
| 20884521083216 | Non-adherent Absorbent Dressing |
| 20884527022516 | Non-adherent Dressing |
| 20884527022523 | Non-adherent Dressing |
| 20884527022547 | Adhesive Dressing |
| 20884527022530 | Adhesive Dressing |
| 20884527021922 | Adhesive Island Dressing |
| 20192253047377 | Telfa Adhesive Island Dressing |
| 20884521083254 | Non-adherent Absorbent Dressing |
| 20884521083247 | Non-adherent Absorbent Dressing |
| 30884521083190 | Non-adherent Absorbent Dressing |
| 30884521065301 | Non-adherent Pad Prepack |
| 20884521065267 | Non-adherent Pad |
| 20884521065229 | Non-adherent Pads Prepack |
Trademark Results [Telfa]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TELFA 71669616 0607346 Live/Registered |
KENDALL COMPANY, THE 1954-07-08 |
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